Methods and apparatus to identify eye coverings for vision

ABSTRACT

Methods and apparatus can fit coverings to treat eyes. The treated eye may comprise a natural eye, for example an eye treated for refractive error with a contact lens, or an eye having an epithelial defect of the eye, such as an eye ablated with PRK refractive surgery. In many embodiments, the covering can be identified so as to provide improved flow of tear liquid under the covering. The covering can be identified based on an inner corneal curvature and an outer corneal curvature and one or more of a limbus sag height or a conjunctival sag height. The covering may form a chamber when placed on the eye to pump tear liquid under at least a portion of the covering. The covering may comprise an outer portion with rigidity to resist movement on the cornea and an inner portion to contact the cornea and provide an environment for epithelial regeneration. The covering may comprise a material having high oxygen permeability, for example silicone, with a wettable coating disposed on at least an upper surface of the coating.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.13/885,135, which is the national of International Application No.PCT/US2011/057755, filed on Oct. 25, 2011, which claims priority under35 U.S.C. 119(e) to U.S. Provisional Application No. 61/406,504 filed onOct. 25, 2010, and U.S. Provisional Application No. 61/480,231, filed onApr. 28, 2011, each of which is incorporated by reference in itsentirety.

BACKGROUND OF THE INVENTION

The present invention is generally directed to vision and treatment ofthe eye to provide improved vision. Although specific reference is madeto coverings for vision correction such as the correction of refractiveerror and also to treatment of eyes having epithelial defects followingphotorefractive keratectomy, embodiments of the present invention maycomprise extended wear contact lenses that can be used to correct visionin many ways such as with one or more of aberration correction,multifocal correction, presbyopia correction, and astigmatismcorrection.

The eye includes several tissues that allow patients to see. The corneaof the eye is an anterior tissue of the eye that is clear in healthyeyes and refracts light so as to form an image on the retina. The retinais a posterior tissue of the eye that senses light from the image formedthereon and transmits signals from the image to the brain. The corneaincludes an outer layer of tissue, the epithelium, which protects theunderlying tissues of the cornea, such as Bowman's membrane, the stromaand nerve fibers that extend into the stroma and Bowman's membrane. Thehealthy eye includes a tear film disposed over the epithelium. The tearfilm can smooth small irregularities of the epithelium so as to providean optically smooth surface. The tear film is shaped substantially bythe shape of the underlying epithelium, stroma, and Bowman's membrane,if present. The tear film comprises a liquid that is mostly water anddoes include additional components, such as mucoids and lipids. The manynerve fibers of the cornea provide sensation to promote blinking thatcan cover the cornea with the tear film. The nerve fibers also sensepain so that one will normally avoid trauma to the cornea and also avoiddirect contact of an object to the cornea so as to protect thisimportant tissue.

Work in relation to embodiments of the present invention suggests thatat least some of the prior contact lenses and therapeutic coverings canbe less than ideal in at least some instances. Many contact lenses andtherapeutic coverings can be left in the eye for less than ideal amountsof time, as the patient removing and replacing the contact lens ortherapeutic covering can be somewhat cumbersome and in at least someinstances patients may leave the contact lens or therapeutic covering inthe eye for amounts of time that can be longer than would be ideal.Although extended wear lenses can be left in the eye for somewhat longeramounts of time, the amount of time such lenses can be left in the eyecan be less than ideal. Work in relation to embodiments of the presentinvention also suggests that tear flow of the prior contact lenses canbe less than ideal, and that less than ideal tear flow may be related tothe potential complications and can limit the amount of time such lensescan be left in the eye.

In the healthy cornea, the proper amount of hydration of the cornea,sometimes referred to as dehydration of the cornea, is maintained suchthat the cornea remains clear. The cornea includes a posteriorendothelial layer that pumps water from the cornea into the adjacentanterior chamber. The epithelium inhibits flow of water from the tearliquid into the cornea, such that the corneal stroma can be maintainedwith the proper amount of hydration with endothelial pumping. Theendothelial pumping of water from the cornea to maintain the properhydration and thickness of the eye is often referred to asdeturgescence. When the corneal epithelium heals, the layer of cellsforming over the defect can be at least somewhat irregular in at leastsome instances, such that the vision of the patient can be less thanideal.

As the post-ablation cornea may have a complex shape, many of the priorcommercially available lenses may not fit the ablated cornea as well aswould be ideal, and in at least some instances fitting of lenses can betime consuming and awkward. Rigid gas permeable (hereinafter “RGP”)lenses can be uncomfortable for the patient and difficult to fit.Commercially available contact lenses having a rigid central portion anda soft peripheral skirt can be difficult and/or time consuming to fit tothe ablated cornea and may not fit very well in at least some instances.The ablated cornea may comprise an abrupt change in curvature near theedge of the ablation, and in at least some instances it can be difficultto fit such lenses near the edge of the ablation. Also, at least some ofthe commercially available contact lenses may not be suitable forextended wear and may be removed each day, which can be somewhat awkwardfor a patient and can result in lack of compliance and lenses remainingin the eye longer than would be ideal in at least some instances.

In light of the above, it would be desirable to provide improved contactlenses for vision correction and coverings for treatments related toepithelial defects of the cornea, such as epithelial defects followingphotorefractive keratectomy (hereinafter “PRK”). Ideally, these contactlenses and coverings would provide treatments that improve tear flow andavoid at least some of the deficiencies of known techniques whileproviding improved patient comfort and/or vision.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provide improved methods andapparatus to fit and identify coverings to treat eyes. The treated eyemay comprise a natural eye, or an eye having an epithelial defect of theeye, such as an eye ablated with PRK refractive surgery. In manyembodiments, the covering can be identified and fit to the eye so as toprovide one or more of improved hydration or flow of tear liquid underthe covering. The covering can be fit and identified based on an innercorneal curvature and an outer corneal curvature and one or more of alimbus sag height or a conjunctival sag height.

The covering to fit the eye may comprise a contact lens and can provideimproved hydration and tear flow such that the covering can be left onthe eye to correct vision for extended amounts of time. The covering maycomprise one or more structures to provide hydration under the coveringsuch that the covering can remain in the eye and correct vision for anextended amount of time. In many embodiments, the covering comprises alayer of hydrogel extending along a lower surface of the covering toprovide hydration to a surface of the eye. Alternatively or incombination, the covering may comprise a material having fenestrationsand an outer portion shaped to contact the conjunctiva to pump tearliquid when the eye blinks. The covering may comprise a deflectableouter portion having a resistance to deflection such that a chamber isformed when the covering is placed on the eye and the eye is open withthe eyelids separated. The resistance to deflection of the deflectableouter portion is configured such that the outer portion deflects inwardtoward the cornea when the eyelid closes to pump tear liquid. Thefenestrations can draw tear liquid into the chamber located under thecovering when the eye opens and the chamber can expand. The outerportion of the covering comprises a sclera coupling portion shaped tocontact the conjunctiva to define the chamber when the covering isplaced on the eye. The fenestrations and sclera coupling portion of thecovering can pass tear liquid away from the chamber when the eye closesand pressure of one or more eyelids urges the covering toward the corneasuch that the chamber volume decreases. In many embodiments, opening ofthe eye so as to separate the eyelids reduces pressure on the outerportion of the covering such that the outer portion of the covering overan outer portion of the cornea can separate from the outer portion ofthe cornea so as to draw liquid through the fenestrations and into thechamber located under the covering. The sclera coupling portion ofcovering may contact the conjunctiva to inhibit the flow of tear liquidunder the sclera coupling portion when the eye opens and tear liquid isdrawn through the fenestrations, for example with formation of a sealwhere the covering contacts the conjunctiva. When the eye blinkssubsequently, the pressure of the one or more eyelids can urge thecovering toward the cornea such that tear liquid can pass through thefenestrations, and the sclera coupling portion may separate slightlyfrom the conjunctiva to pass tear liquid under the sclera couplingportion, so as to rinse the cornea, the limbus, the conjunctiva and theunderside of the covering with the pumped tear liquid. The covering maycomprise a material having high oxygen permeability such as siliconesuch that the covering may provide improved tear flow and high oxygenpermeability. This improved flow of tear liquid can allow the coveringsuch as a contact lens to be worn for extended amounts of time of atleast about one week, for example thirty days or sixty days or more. Theimproved tear flow can improve healing and vision of eyes withepithelial defects, for example epithelial defects following PRK.

In many embodiments, the identified covering comprises an inner opticalcomponent for vision, such as a lens, and an outer coupling component tohold the inner component in relation to the pupil to improve vision. Thecoupling component may comprise a deflectable material that inhibitspassage of the tear liquid through the material such that the tearliquid passes through the fenestrations when the eye blinks and aneyelid exerts pressure on the optical component. The outer couplingcomponent may comprise the fenestrations to pass the tear liquid and theouter sclera coupling portion to contact the conjunctiva. The opticalcomponent may comprise a first material and first thicknesscorresponding to a first rigidity. The coupling component may comprise asecond material and a second thickness corresponding to a secondrigidity. The second material can be softer than the first material andthe second thickness can be less than the first thickness such that thecoupling component can be deflected with the eyelid, and such that thecoupling component can be deflected by an amount greater than theoptical component when the eyelids close to cover the first componentand the second component. The optical component can be more rigid thanthe coupling component, such that the optical component can providevision when the outer portion is deflected with one or more eyelids.

The covering can be identified such that the alignment of the opticalcomponent to the pupil provided with the coupling to the conjunctiva andunderlying sclera can be beneficial for vision. The optical componentcan be held at a substantially fixed location in relation to the pupilso as to provide improved vision such as presbyopia correction andvision correction of aberrations that may depend on location of thepupil such as measured wavefront aberrations, spherical aberration, comaand trefoil.

The covering can be identified such that the optical component andcoupling component can be helpful to improve vision and regeneration ofthe epithelium in eyes with epithelial defects. The optical componentcan smooth the cornea and may smooth irregularities of the epitheliumand ablated stroma. The coupling component can support the opticalcomponent so as to resist sliding movement of the optical component andprovide an environment to promote regeneration of the epithelium. Thepumping of the tear liquid may improve tear flow to the regeneratingepithelium near the epithelial defect so as to promote regeneration ofthe epithelium over the defect. The pumping of the tear liquid can alsopromote delivery of a medicament, for example a steroid, to the ablatedregion so as to inhibit corneal infiltrates and haze.

In many embodiments, the covering can be identified based on one or moreof pre-operative eye data used to determine the ablation, ablation dataof the laser such as the amount of ablative correction, and dimensionsacross the ablated region of the eye. The covering may comprise an innerportion having a lower surface comprising a curvature, and the curvaturecan be less than a curvature of the ablated profile to improve visionand inhibit formation of one or more irregularities of the epithelium.The one or more irregularities may be located on an inner portion of theablation comprising a center of the ablation, and the covering maycomprise a resistance to deflection to inhibit formation of the one ormore irregularities near the center of the ablation. The irregularitymay comprise an elevated profile of the epithelium located on the innerportion comprising the center of the ablation, and the inner portion ofthe covering may comprise resistance to deflection and provide pressurein response to deflection of the inner portion so as to inhibitformation of the one or more irregularities of the epithelium. As thecovering can resist deflection, the covering can be identified based oneye measurement data and ablation data so as to provide comfort andimproved vision to the patient when the covering is placed on the eyeand improves vision. A plurality of coverings having portions sized tofit the patient can be provided. A covering to treat the patient can beidentified among the plurality of coverings based on data correspondingto an untreated portion of the eye, data corresponding to a treatedportion of the eye, and an array of data corresponding to rigidity ofthe plurality of coverings. The array of data may comprise the uniqueidentifiers arranged such that the unique identifier can be determinedfrom the array based on the data corresponding to an untreated portionof the eye and the data corresponding to a treated portion of the eye.The identified covering can be placed on the eye and promoteregeneration of the epithelium with improved vision and comfort.

In a first aspect, embodiments provide a method of treating an eye of apatient, in which the eye has a cornea. The eye is measured to determinedata of the eye corresponding to an inner ablated portion of the corneaand an outer unablated portion of the cornea away from the ablatedportion. A covering of a plurality of coverings is identified to treatthe eye based on the data of the eye and an array of data correspondingto the plurality of therapeutic coverings.

In many embodiments, the covering is placed on the eye.

In many embodiments, the covering comprises an inner covering portionand an outer covering portion, the inner covering portion contacting theinner ablated portion of the cornea and an outer covering portioncontacting an unablated portion when placed on the cornea and whereinthe inner covering portion prior to placement on the eye has a coveringcurvature no more than a curvature of the ablated portion of the corneaand wherein the outer covering portion comprises a curvature prior toplacement on the eye no more than the outer unablated portion of thecornea and wherein the covering resists movement of the inner portionwhen placed on the eye.

In many embodiments, the outer portion of the covering extends to aconjunctiva of the eye and couples to the sclera of the eye to resistmovement of the inner portion.

In many embodiments, the inner portion of the covering prior toplacement comprises a substantially uniform thickness and an amount ofcurvature corresponding to less optical power than the optical power ofthe ablated portion of the cornea, the amount of curvature of the innerportion prior to placement within a range from about −1D to about −3Drelative to the ablated portion of the cornea.

In many embodiments, the inner portion of the covering deflects at leastabout 1D so as to conform at least partially to the ablation and promotesmooth epithelial regeneration and vision.

In many embodiments, the inner portion of the covering comprises anamount of rigidity within a range from about 1E-4 to about 5E-4 (Pa*m̂3)and the outer portion of the covering comprises an outer amount ofrigidity less than the amount of rigidity of the inner portion.

In many embodiments, measuring the eye comprises determining aconjunctiva sag height, in which the conjunctiva sag height correspondsto a portion of a conjunctiva of the eye at a radial location away froma reference axis of the eye. The covering comprises a covering sagheight at a covering location corresponding to the radial location ofthe portion of conjunctiva, and the covering is identified such that thecovering sag height is greater than the conjunctiva sag height.

In many embodiments, the covering is deflected at the covering locationwhen the covering is placed on the eye.

In many embodiments, the conjunctiva sag height is determined based on ameasurement of a sclera of the eye corresponding to the radial location.

In many embodiments, measuring the eye comprises determining a limbussag height, the limbus sag height corresponding to a portion of a limbusof the eye at a radial location away from a reference axis of the eyeand wherein the covering comprises a covering sag height at a coveringlocation corresponding to the radial location of the portion of thelimbus and wherein the covering is identified such that the covering sagheight is no more than the limbus sag height.

In many embodiments, the covering is deflected a first amount at a firstcovering location corresponding to a portion of the conjunctiva when thecovering is placed on the eye and wherein the covering is deflected asecond amount at a second covering location corresponding to a portionof the limbus when the covering is placed on the eye, the second amountless than the first amount such that pressure from the covering to thelimbus is inhibited.

In many embodiments, the covering comprises an inner portion having ahydrogel layer extending along a lower surface to contact the ablatedportion and the unablated portion of the cornea and wherein the coveringcomprises an outer portion comprising a sticky, tacky surface to contactthe conjunctiva and inhibit movement of the covering when the innerportion contacts the cornea

In another aspect, embodiments provide an apparatus to treat an eye. Theapparatus comprises an input to receive data of the eye. The data of theeye corresponds to an inner ablated portion of the cornea and an outerportion of the cornea away from the inner ablated portion. The apparatuscomprises an output. At least one processor is coupled to the input andthe output. The at least one processor comprises at least one computerreadable memory. The at least one computer readable memory hasinstructions to store an array of data corresponding to a plurality oftherapeutic coverings and instructions to identify a covering of theplurality based on the array and the data of the eye corresponding tothe inner ablated portion and the outer portion.

In many embodiments, the apparatus comprises the plurality of coverings.

In many embodiments, the instructions are configured to identify acovering having an inner portion comprising a lower surface curvatureflatter than the inner ablated portion of the eye to inhibit one or moreirregularities of the epithelium.

In many embodiments, the lower surface curvature of the identifiedcovering is flatter prior to placement than the inner ablated portion ofthe eye by at least about 1D.

In many embodiments, the inner portion of the covering comprises asubstantially uniform thickness and the instructions are configured toidentify a covering prior to placement corresponding to hyperopia of theeye to improve vision and inhibit an epithelial irregularity located onan inner portion of the ablation and corresponding to nearsightedness ofthe eye.

In many embodiments, the instructions are configured to identify thecovering to inhibit formation of the epithelial irregularity based onone or more of a modulus of the inner portion of the covering, athickness of the inner portion of the covering, or an amount of rigidityof the inner portion of the covering.

In many embodiments, the array of data comprises a plurality of uniqueidentifiers corresponding to the plurality of coverings.

In many embodiments, the plurality of unique identifiers corresponds toa rigidity of an inner portion of each of the plurality of coverings.

In many embodiments, the covering comprises an amount of rigidity of theinner portion within a range from about 1E-4 Pa*m̂3 to about 5E-4 Pa*m̂3.

In many embodiments, the plurality of unique identifiers comprises 10 ormore unique identifiers corresponding to an amount of rigidity of theinner portion of at least about 3E-4 Pa*m̂3.

In many embodiments, the covering comprises an amount of rigidity of theinner portion within a range from about 1E-4 Pa*m̂3 to about 5E-4 Pa*m̂3.

In many embodiments, the array of data comprises a first dimensioncorresponding to the inner ablated portion and a second dimensioncorresponding to the outer portion away from the ablated portion.

In many embodiments, the array comprises a table, the first dimensioncorresponding to rows of the table, the second dimension correspondingto columns of the table and wherein the plurality of unique identifiersis stored in the rows and the columns of the table.

In many embodiments, the display is visible to the user and theinstructions are configured to show the unique identifier on thedisplay.

In many embodiments, the instructions are configured to receive aconjunctiva sag height, the conjunctiva sag height corresponding to aportion of a conjunctiva of the eye at a radial location away from areference axis of the eye. The instructions are configured such that theidentified covering comprises a covering sag height at a coveringlocation corresponding to the radial location of the portion ofconjunctiva and wherein the instructions are configured such that thecovering sag height is greater than the conjunctiva sag height.

In many embodiments, the covering comprises an inner portion having ahydrogel layer extending along a lower surface to contact the ablatedportion and the unablated portion of the cornea, and the coveringcomprises an outer portion at the covering location comprising a stickytacky surface to contact the conjunctiva and inhibit movement of thecovering when the inner portion contacts the cornea.

In many embodiments, the inner portion of the covering comprises a lowwater content water inhibiting layer beneath the hydrogel layer, and theouter portion of the covering at the covering location to contact theconjunctiva comprises a soft hydrophobic material.

In many embodiments, the water inhibiting layer comprises siliconeelastomer and the hydrogel layer comprises silicone hydrogel.

In many embodiments, instructions are configured such that theidentified covering is deflected at the covering location when thecovering is placed on the eye.

In many embodiments, the instructions are configured to receive theconjunctiva sag height based on a measurement of a sclera of the eyecorresponding to the radial location.

In many embodiments, the instructions are configured to receive ameasurement the eye corresponding to a limbus sag height, in which thelimbus sag height corresponds to a portion of a limbus of the eye at aradial location away from a reference axis of the eye. The instructionsare configured such that the covering comprises a covering sag height ata covering location corresponding to the radial location of the portionof limbus, and the instructions are configured such that the coveringsag height is no more than the limbus sag height.

In many embodiments, the instructions are configured to identify thecovering such that the identified covering is deflected a first amountat a first covering location corresponding to a portion of theconjunctiva when the covering is placed on the eye, and the instructionsare configured to identify the coveringsuch that the covering isdeflected a second amount at a second covering location corresponding toa portion of the limbus when the covering is placed on the eye, thesecond amount less than the first amount such that pressure from thecovering over the limbus is inhibited.

In another aspect embodiments provide an apparatus to treat an eye. Theapparatus comprises an input, an output and at least one processor. Theinput is configured to receive data of the eye, and the data of the eyecorrespond to an inner portion of the cornea and one or more of a limbusor a conjunctiva of the eye. The at least one processor is coupled tothe input and the output. The at least one processor comprises at leastone computer readable memory. The at least one computer readable memoryhas instructions to store an array of data corresponding to a pluralityof coverings and instructions to identify a covering of the pluralitybased on the data of the eye and the array of data corresponding to theplurality of coverings, such tear liquid is pumped under the coveringwhen the eye blinks.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an eye suitable for incorporation of the covering asdescribed herein, in accordance with embodiments of the presentinvention;

FIG. 1-1A shows an ablated eye immediately following refractive surgeryresulting in an epithelial defect, suitable for incorporation inaccordance with embodiments of the present invention;

FIG. 1-1B shows an ablated eye about 1 day following refractive surgeryresulting in an epithelial defect, suitable for incorporation, inaccordance with embodiments of the present invention;

FIG. 1-1C shows an ablated eye when the epithelium has regeneratedfollowing refractive surgery resulting in an increased epithelialthickness centrally at about 3 days, suitable for incorporation, inaccordance with embodiments of the present invention;

FIG. 1-2A shows a covering positioned on an eye having an epithelialdefect, in which the covering abuts the cornea to seal the cornea, inaccordance with embodiments of the present invention;

FIG. 1-2B shows a smooth layer of regenerated epithelium substantiallycover an ablated profile, in accordance with embodiments of the presentinvention;

FIG. 1A shows a covering positioned on an eye having an epithelialdefect, in which an outer portion of the covering abuts and conforms atleast partially to the cornea to seal the cornea, in accordance withembodiments of the present invention;

FIG. 1A1 shows a covering positioned on an eye and blinking of the eye,in accordance with embodiments of the present invention;

FIG. 1B1 shows a covering sized to seal a cornea, in accordance withembodiments of the present invention;

FIG. 1B2 shows the covering conforming to ablated stromal tissue andguiding regeneration of the epithelium over the ablated stroma, so as topromote vision, in accordance with embodiments of the present invention;

FIG. 1B2A shows a covering forming an indentation in the epithelium suchthat the epithelium extends over at least a portion of the perimeter ofthe covering, in accordance with embodiments of the present invention;

FIG. 1B2B shows a covering forming an indentation in the epithelium, inaccordance with embodiments of the present invention;

FIG. 1B2C shows a covering abutting the cornea to seal the corneawithout forming a substantial indentation in the epithelium, inaccordance with embodiments of the present invention;

FIG. 1C shows a covering comprising a single piece of material having aninner thickness greater than an outer thickness, in accordance withembodiments of the present invention;

FIG. 1C1 shows a covering as in FIGS. 1-2A to 1B2 having an innerportion comprising an inner thickness and an inner material and an outerportion comprising an outer thickness and an outer material, in whichthe inner thickness is greater than the outer thickness, in accordancewith embodiments of the present invention;

FIG. 1C1A shows a covering as in FIG. 1C1 adhered to the cornea with asmooth upper surface and a lower surface conforming to irregularity ofthe cornea comprising a central island of the stroma, in accordance withembodiments of the present invention;

FIG. 1C2 shows a covering as in FIGS. 1-2A to 1B2 having an innerportion comprising an inner thickness and an inner material and an outerportion comprising an outer thickness and an outer material, in whichthe inner thickness is greater than the outer thickness and the outermaterial extends around the inner material, in accordance withembodiments of the present invention;

FIG. 1C2A shows a covering as in FIG. 1C1 adhered to the cornea with asmooth upper surface and a lower surface conforming to irregularity ofthe cornea near the edge of the ablation, in accordance with embodimentsof the present invention;

FIG. 1C2A1 shows a covering having a layer of hydrogel material on aposterior surface of the covering, in accordance with embodiments of thepresent invention;

FIG. 1C2B shows a covering having a layer of hydrogel material on aposterior surface of the covering extending less than a maximum distanceacross the covering such that end portions of the covering areconfigured to engage the epithelium of the eye away from the hydrogellayer and inhibit movement of the covering when placed on the eye, inaccordance with embodiments of the present invention;

FIG. 1C2C shows a covering having an annular layer of hydrogel materialon a posterior surface of the covering such that an inner portion of thecovering contacts the cornea away from the hydrogel layer and an outerportion of the covering contacts the cornea away from the covering whenplaced on the eye, in accordance with embodiments of the presentinvention;

FIG. 1C3 shows a covering having a tricurve profile to fit sclera withslopes of the curved profiles aligned so as to inhibit ridges at theboundaries of the curved portions as in FIG. 1B2 and having a layer ofhydrogel material on a lower surface, in accordance with embodiments ofthe present invention;

FIG. 1C4 shows a side cross-sectional view covering having a tricurveprofile to fit the cornea, limbus and sclera with slopes of the curvedprofiles aligned so as to inhibit ridges at the boundaries of the curvedportions and having a hydrogel material on a lower surface extendingless than a maximum distance across the covering to engage theconjunctiva with the covering away from the hydrogel material, inaccordance with embodiments of the present invention;

FIG. 1C5 shows a fenestration having a posterior end covered with alayer of hydrogel extending along the posterior surface of the covering,in accordance with embodiments of the present invention;

FIG. 1C6 shows a fenestration extending through a layer of hydrogelextending along the posterior surface of the covering, in accordancewith embodiments of the present invention;

FIG. 1D shows a covering as in FIGS. 1-2A to 1B2 having an inner portioncomprising an inner thickness and an inner material and an outer portioncomprising an outer thickness and an outer material, in which the innerthickness is substantially similar to the outer thickness, in accordancewith embodiments of the present invention;

FIGS. 1E and 1F show top and side views, respectively, of a coveringcomprising an inner portion and an outer portion, as in FIGS. 1A to 1B2and a peripheral rim portion disposed around the outer portion, inaccordance with embodiments of the present invention;

FIG. 1G shows a covering comprising an inner portion and an outerportion comprising a taper, in accordance with embodiments of thepresent invention;

FIG. 1G1 shows a covering comprising an inner portion and an outerportion comprising a taper and an outer rim of substantially uniformthickness peripheral to the taper, in accordance with embodiments of thepresent invention;

FIGS. 1G1A to 1G1G show a covering as in FIG. 1G1 and dimensionssuitable for use with experiments, clinical studies, and patienttreatment, in accordance with embodiments of the present invention;

FIG. 1H1 shows spatial frequency and elevation smoothing of anepithelial irregularity transferred to a front surface of a covering asin FIG. 1-2A, in accordance with embodiments of the present invention;

FIG. 1H2 shows spatial frequency and elevation smoothing of theepithelial irregularity with a plot of height relative to a referencesphere for the upper surface of the covering and the upper surface ofthe irregularity, in accordance with embodiments of the presentinvention;

FIG. 1I1 shows inhibition of transfer of an epithelial irregularity to afront surface of a covering, in accordance with embodiments of thepresent invention;

FIG. 1I2 shows elevation smoothing of the epithelial irregularity with aplot of height relative to a reference sphere for the upper surface ofthe covering and the upper surface of the irregularity, in accordancewith embodiments of the present invention;

FIG. 1I3 shows a thickness profile of the covering as in FIG. 112 so asto smooth the front surface of the covering, in accordance withembodiments of the present invention;

FIG. 1J1 shows a covering having a bicurve profile to fit an ablatedcornea, in accordance with embodiments of the present invention;

FIG. 1J2 shows a covering having an oblate profile to fit an ablatedcornea, in accordance with embodiments of the present invention;

FIG. 1J3 shows a covering having a tricurve profile to fit sclera and anablated cornea, in accordance with embodiments of the present invention;

FIG. 1J4 shows a covering having a curved profile to fit sclera and anoblate profile to fit ablated cornea, in accordance with embodiments ofthe present invention;

FIG. 1J5 shows a covering having a tricurve profile to fit sclera and anablated cornea similar to FIG. 1J3, in accordance with embodiments ofthe present invention;

FIG. 1J6 shows a tapered edge of the covering having a tricurve profileto fit sclera and an ablated cornea as in FIG. 1J5, in accordance withembodiments of the present invention;

FIG. 1K shows a covering having fenestrations on an outer portion topass a medicament when the cornea is sealed, in accordance withembodiments of the present invention;

FIG. 1L shows fitting of a covering to a cornea, in accordance withembodiments of the present invention;

FIG. 1M shows deflection of a portion of a covering in response to anepithelial irregularity so as to smooth the irregularity, in accordancewith embodiments as described herein;

FIG. 1N shows a test apparatus to measure deflection of a portion of alens in response to a load, in accordance with embodiments as describedherein;

FIG. 2A1 shows a covering positioned on an eye and blinking of the eye,in accordance with embodiments of the present invention;

FIG. 2A2 shows the covering of FIG. 2A1 that is capable of pumping tearliquid under the covering, in accordance with embodiments of the presentinvention;

FIG. 2A3 shows a schematic illustration of the covering of FIGS. 2A1 and2A2 pumping tear liquid when the eye closes, in accordance withembodiments of the present invention;

FIG. 2A4 shows a schematic illustration of the covering of FIGS. 2A1 and2A2 pumping tear liquid when the eye opens, in accordance withembodiments of the present invention;

FIG. 2B1 shows a covering having a tricurve profile to fit sclera, whichcovering may be used to fit an ablated cornea, in accordance withembodiments of the present invention;

FIG. 2B2 shows a covering having a tricurve profile to fit sclera withslopes of the curved profiles aligned so as to inhibit ridges at theboundaries of the curved portions, in accordance with embodiments of thepresent invention;

FIG. 2B2-1 shows alignment of the slope of the lower surface of thecorneal contacting portion with the slope of the lower surface of thesclera coupling portion, such that pressure to the limbus is decreasedsubstantially, in accordance with embodiments of the present invention;

FIG. 2B3 shows a tapered edge of the covering of FIG. 2B1, in accordancewith embodiments of the present invention;

FIG. 2B4 shows a plan view of the covering having a tricurve profile tofit the cornea, limbus, and sclera with slopes of the curved profilesaligned so as to inhibit ridges at the boundaries of the curvedportions, in accordance with embodiments of the present invention;

FIG. 2B5 shows a side sectional view of the covering of FIG. 2B4 andcorresponding curved portions to couple to the cornea, limbus and,sclera, in accordance with embodiments of the present invention;

FIG. 2B6 shows a side sectional view of the covering of FIG. 2B4 andcorresponding curved portions of the upper surface, in accordance withembodiments of the present invention;

FIG. 2B7 shows a tapered edge of the covering of FIG. 2B4, in accordancewith embodiments of the present invention;

FIG. 3A shows a covering comprising a contact lens placed on the eyewith the eyelids separated, in accordance with embodiments of thepresent invention;

FIG. 3B shows a side sectional view of the covering of FIG. 3A with theeyelids closing, in accordance with embodiments of the presentinvention;

FIG. 3C shows a front view the covering of FIG. 3A with the eyelidsclosing, in accordance with embodiments;

FIG. 3D shows side profile the covering of FIG. 3A with the eyelidsopening, in accordance with embodiments of the present invention;

FIG. 3E shows a covering comprising a contact lens placed on the eyesuch that the covering is supported with an inner portion of the corneaand the conjunctiva with the covering separated from an outer portion ofthe cornea so as to define a chamber when the eyelids are separated, inaccordance with embodiments of the present invention;

FIG. 3F shows a side sectional view of the covering of FIG. 3E with theeyelids closing, in accordance with embodiments of the presentinvention;

FIG. 3F1 shows a side sectional view of the covering of FIG. 3F withrotation of the eye when the lids close such that sliding of thecovering along the epithelium is inhibited when tear liquid is pumped,in accordance with embodiments of the present invention;

FIG. 3G shows a side sectional view of the covering of FIG. 3E with theeyelids opening, in accordance with embodiments of the presentinvention;

FIG. 3H shows a side sectional view of the covering of FIG. 3E with theeyelids located at an intermediate location such that the chambercomprises an intermediate volume, in accordance with embodiments of thepresent invention;

FIG. 3I shows a side sectional view of the covering of FIG. 1C4 placedon the eye with hydrogel contacting the eye, in accordance withembodiments of the present invention;

FIG. 4 shows apparatus and coverings to treat an eye, in accordance withembodiments of the present invention;

FIG. 4A shows data structures and a method of identifying a covering, inaccordance with embodiments of the present invention; and

FIG. 4B shows data structures and the method of identifying the coveringas FIG. 4A, in which the fit parameters comprise a two fit parametersand the data array comprises a two dimensional look up table, inaccordance with embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present invention as described herein can be combinedwith the therapeutic covering device for pain management and vision asdescribed in U.S. patent application Ser. No. 12/384,659, filed Apr. 6,2009, entitled “Therapeutic Device for Pain Management and Vision”, thefull disclosure of which is incorporated herein by reference andsuitable for combination in accordance with some embodiments of thepresent invention as described herein.

The embodiments described herein can be used to treat eyes in many wayswith a covering. Although specific reference is made to treatingepithelial defects of the eye, the covering described herein can be usedfor long term vision correction with extended wear contact lenses thatinhibit swelling of the cornea when the covering is positioned on theeye for an extended period.

The coverings as described herein can seal the cornea, so as to restoredeturgescence of the cornea to decrease pain and improve vision. Thecovering can be configured in many ways to seal the cornea, and thecovering comprises a substantially oxygen permeability to promote growthof the epithelium and to guide the growth of the epithelium such thatthe epithelium regenerates smoothly for patient vision. The restorationof deturgescence of the cornea can decrease irregularities of the corneasuch as ablated stromal irregularities, for example central islands. Thesealing of the cornea with the environment to promote epithelialregeneration can result in improved epithelial smoothness and animproved profile of the ablated stromal surface under the regeneratingepithelium.

In many embodiments, the covering comprises an at least partiallyconformable portion, such that the at least partially conformableportion can one or more of match or grossly approximate the correctedcorneal curvature so as to provide vision of at least about 20/30, andsuch that the at least partially conformable portion substantially doesnot conform to the corneal irregularities caused by epithelial healingand edema, such as irregularities of the epithelium and central islandsthat may appear post-ablation in ablated eye.

In many embodiments, the at least partially conformable portion of thecovering can be configured so as to conform at least partially to theepithelium when the covering is positioned on the epithelium so as todeflect the epithelium.

The epithelium can conform to the covering so as to seal the covering,for example with deformation of the epithelium such as with one or moreof indentation or overgrowth of the epithelium around a perimeter of thecovering.

In many embodiments, the curvature of the covering can matchsubstantially the profile of the ablated region, so as to providevisions of at least about 20/30 when positioned on the cornea.

As used herein, mathematical equations and scientific notation can beused to values in many ways understood by a person of ordinary skill inthe art, for example so as to express data in accordance with notationsused in many commercially available spreadsheets such as Excel™commercially available from Microsoft. As used herein the symbol “E” canbe used to express an exponent in base 10, such that 1E1 equals about10, 2E1 equals about 20, and 4E2 equals about 400. As used herein thesymbol “̂” can be used to express an exponent, such that ÂB equals A^(B).Units can be expressed in many ways and as would be understood by aperson of ordinary skill in the art, for example “m” as meters, “Pa” asthe Pascal unit for pressure, and “MPa” as Mega Pascal.

FIG. 1 shows an eye 2 suitable for incorporation of the covering 100 asdescribed herein. The eye has a cornea 10 and a lens 4 configured toform an image on the retina 5, and the image can form on a fovea 5Fcorresponding to high visual acuity. The cornea can extend to a limbus 6of the eye, and the limbus can connect to a sclera 7 of the eye. The eye2 has a pars plana PP located near limbus 6. A conjunctiva 7C of the eyecan be disposed over the sclera 7. The lens can accommodate to focus onan object seen by the patient. The eye has an iris 8 that defines apupil 9 that may expand and contract in response to light. The eye alsocomprises a choroid CH disposed between the sclera 7 and the retina 5.The eye has a vitreous humor VH extending between the lens and theretina. The retina 5 senses light of the image and converts the lightimage to neural pulses that are processed and transmitted along an opticnerve ON to the brain of the patient.

FIG. 1-1A shows an ablated eye immediately following refractive surgery,for example PRK surgery resulting in an epithelial defect. The eye 2comprises an iris 8 that defines a pupil 9, through which light passessuch that the patient can see. Cornea 10 includes an epithelium 12disposed over a stroma 16. The epithelium 12 comprises an unablatedouterperipheral portion having 12P having a thickness 12T that can beabout 50 um. A tear liquidcovers the anterior surface of epithelium 12.In at least humans, primates and some birds, a Bowman's membrane 14 isdisposed between epithelium 12 and stroma 16. Bowman's membrane 14comprises an acellular substantially collagenous tissue with a thicknessof about 5 to 10 microns. Stroma 16 comprises a substantiallycollagenous tissue with keratocytes disposed therein. In some animals,Bowman's membrane may be absent and the epithelium may be disposedadjacent to the stromal layer. An endothelium 18 is disposed understroma 16. Endothelium 18 comprises a layer of cells that pump waterfrom cornea 10 toward iris 8. Tear liquid also covers surfaces of thecornea that are exposed by the epithelial defect, such as an exposedsurface of Bowman's membrane and an exposed stromal surface.

In a normal healthy eye, epithelium 12 is disposed across cornea 10 andis a protective layer. Epithelium 12 covers nerves of the cornea andminimizes the flow of water from the tear film of the eye to into thestroma. Epithelium 12 in most human patients can be about 40 to 60microns thick, for example about 50 microns. When epithelium 12 isintact, endothelium 18 can pump water from stroma 16 and maintainhydration in the cornea at a proper level. The mechanism by which thestroma of the cornea remains properly hydrated can be referred to asdeturgescence. Deturgescence of the cornea can be important becauseexcess hydration of the cornea can result in swelling of the cornea andlight scattering, or haze, that can degrade vision. The total thicknessof normal cornea 10 from endothelium 18 to tear liquid in most humanpatients can be from about 400 to 600 microns. A healthy cornea withnormal hydration comprises about 80 to 85% water. Edema of the corneadue to swelling of the cornea, for example with additional water, canincrease the thickness of the cornea.

With refractive surgery, for example PRK, the epithelium can be removedto ablate a refractive correction into Bowman's membrane 14 and/orstroma 16. An initial profile of the anterior surface of stroma and/orBowman's membrane is ablated to an ablated profile 20 to correct thepatient's vision. The profile of tissue removed to correct vision isdescribed in U.S. Pat. No. 5,163,934, entitled “PhotorefractiveKeratectomy”, the disclosure of which may be suitable for combination inaccordance with some embodiments of the present invention describedherein. Ablated profile 20 generally comprises an optical zone thatextends across the cornea to correct refractive error of the eye and maycorrect aberrations of the eye, for example wavefront aberrations.Ablated profile 20 is bounded by boundary 20B that may circumscribe theablated profile. The ablation profile 20 comprises a maximum dimensionacross, for example a diameter 20D.

The epithelium may comprise an inner boundary that moves centripetallyinward as indicated by arrows 30

FIG. 1-1B shows an ablated eye about 1 to 2 days following refractivesurgery resulting in an epithelial defect. The epithelium has at leastpartially covered the ablation. The epithelium may compriseirregularities and an inner boundary that moves centripetally inward asindicated by arrows 30. The thickness profile 12RP of the regeneratingepithelium 12R can be irregular and degrade vision. The inner portion ofthe epithelium near the boundary may comprise a height greater than anouter portion of the epithelium away from the boundary of theepithelium. The portion of the ablation not covered with the epitheliumand the inner portion of the epithelium near the boundary can result inaberrations, for example aberrations corresponding to a meniscus of thetear and a far sighted portion of the cornea. As variation in epithelialhealing among individuals can be observed, the epithelial defect of atleast some individuals can be present at 2 and 3 days post-op, withcorresponding aberrations.

FIG. 1-1C shows an ablated eye when the epithelium has regeneratedfollowing refractive surgery resulting in an increased epithelialthickness centrally when the epithelium has regenerated, for example atabout 3 days post-op. The regenerating epithelium may have anirregularity 12I, for example corresponding to an increased elevation ofan inner portion of the epithelium near the center of the ablation, forexample. Work in relation to embodiments as described herein suggeststhat the natural regeneration of the epithelium can provide an innerportion having an increased central elevation with optical power thatmay correspond to about 1 to 3 Diopters of additional optical power. Theregenerating epithelium comprises a thickness profile 12RP extendingalong the surface of Bowman's membrane 14 and the ablation 20. With PRKthe thickness profile 12RP of the epithelium can regenerate for at leastone week, for example one month, such that vision can be degraded whenthe thickness profile 12RP of the epithelium regenerates, and PRKsurgery of the cornea can be combined in accordance with embodimentsdescribed herein so as to improve vision.

In many embodiments as described herein, irregularities of the corneaare decreased when the epithelium regenerates so as to provide one ormore of improved vision or comfort. The coverings as described hereincan be configured so as to decrease an effect on vision of cornealirregularity 12I, decrease the height profile of irregularity 12I,decrease transfer of irregularity 12I to an anterior surface of thecovering, smooth irregularity 12I with the covering, regenerateepithelium 12 such that irregularity 12I is decreased, or combinationsthereof. In many embodiments, the covering 100 as described herein canbe placed on the eye such that a smooth layer 12S of regeneratedepithelium 12R substantially covers the ablated profile so as to provideimproved vision sooner than would occur without covering, for example atabout 3 to 4 days post-op with PRK. In many embodiments, the coveringcan provide an environment 100E as described herein so as to guideepithelial regeneration and smooth the regenerated epithelium.

In many embodiments, the cornea 10 of an eye 2 has an epithelial defect11 following refractive surgery such as PRK, and a covering 100positioned over the epithelial defect 11.

FIG. 1-2A shows a covering 100 positioned on cornea 10 an eye 2 havingan epithelial defect 11, in which the covering abuts the cornea to sealthe cornea. The covering may comprise a curved body, for example acurved contact lens body shaped to fit the cornea.

The covering 100 can be sized to cover the ablated profile andepithelial defect. The inner portion 110 comprises a dimension across102 that can be sized to extend across a majority of the ablation, andthe outer portion 120 comprises a dimension across 104 sized to extendacross at least the epithelial defect and contact the epithelium onopposite sides of the defect.

The dimension 102 extending across a majority of the ablation may extendabout 6 to 8 mm, for example, and may be sized larger than the ablation.The dimension 104 may comprise about 12 to 14 mm across, for example soas to extend to the limbus and can be sized to the limbus of the patientfor example. Work in relation to embodiments suggests that the coveringsized to extend to the limbus and circumferentially around the limbuscan be centered on the cornea. The covering may extend such that theouter rim of the covering contacts the conjunctiva disposed above thesclera peripheral to the limbus, for example, and that suchconfigurations may center the lens on the cornea, for example.

The thickness of the covering can be sized and shaped in many ways. Theinner portion 110 of the covering comprises a thickness 106 and theouter portion 120 of the covering comprises a thickness 108. Thethickness 106 of the inner portion may comprise a substantially uniformthickness such that the inner portion comprises an optical power of nomore than about +/−1D prior to placement on the eye, for example whenheld in front of the eye and separated from the cornea by a distance.Alternatively, the thickness of the inner portion may vary so ascomprise optical power, for example optical power to correct vision ofthe patient.

FIG. 1-2B shows a smooth layer 12S of regenerated epithelium 12Rsubstantially covering an ablated profile. The environment 100E isconfigured to guide epithelial regeneration and smooth the regeneratedepithelium. The regenerating epithelium comprises a thickness profile12RP.

The epithelium grows centripetally from circumscribing boundary 12Etoward the center of ablated profile 20 to cover the exposed stroma, asindicated by arrows 30.

The covering 100 may comprise an inner portion 110 and an outer portion120. The outer portion 120 can be configured to form a seal 100S withthe cornea near the edge of the ablation and the epithelial defect, forexample with a soft conformable material such as silicone or siliconehydrogel. The inner portion 110 is positioned over the pupil andconfigured for the patient to see, and may comprise a rigidity greaterthan the outer portion, so as to smooth irregularities of the epitheliumwhen the cornea heals. Alternatively, the inner portion may comprise arigidity equal to or less than the rigidity of the outer portion aswell. For example, the inner portion may comprise silicone and the outerportion may comprise silicone, and the inner portion may comprise one ormore of a more rigid silicone or a greater thickness such that the innerportion can be more rigid than the outer portion so as to smooth theepithelium. Although the inner portion can be more rigid than the outerportion, the inner portion is sufficiently soft, flexible andconformable so as to conform at least partially to the ablated profile20 in the stroma, such that the patient receives the benefit of thevision correction with the ablation profile 20 when the patient looksthrough the inner portion and the inner portion smoothes the epithelium.Work in relation to embodiments of the present invention suggests thatthe regenerating epithelium is softer than the underlying stroma ofablation profile 20, such that the inner portion can be configured toconform to the shape of the ablation profile 20 when the inner portionsmoothes the epithelium disposed under the inner portion.

The covering 100 may comprise one or more of many optically clearmaterials, for example synthetic materials or natural material suchcollagen based materials, and combinations thereof, such as described inU.S. patent application Ser. No. 12/384,659, filed Apr. 6, 2009,entitled “Therapeutic Device for Pain Management and Vision”, U.S. Pub.No. US 2010-0036488 A1, published on 11 Feb. 2010. For example, the lensmaterial may comprise a naturally occurring material, such as collagenbased material. Alternatively or in combination, the lens material maycomprise a known synthetic material, for example hydroxyethylmethacrylate (HEMA) hydrogel, hydrogel, silicone, for example hydratedsilicone and derivatives thereof. For example, the optically clearmaterial may comprise one or more of silicone, silicone hydrogel,silicone comprising resin, silicone comprising silicate, acrylate,orcollagen. The cured silicone may comprise silicone that is two-partheat cured and RTV (room temperature vulcanized). For example,polydimethyl siloxane such as NuSil, or poly(dimethyl) (diphenyl)siloxane may be used to mold the covering, for example with less than10% water content so as to increase oxygen diffusion through thecovering. The covering 100 may comprise perfluoropolyethers orfluorofocal. The lens material can be elastic, for example a stretchableelastic material such as silicone, such that the lens can seal thecornea. The lens material can be cured with a hardness and size andshape such that the covering comprises a modulus within a range fromabout 4 to about 20 MPa. The material may comprise, for example,silicone elastomer having optically clear silicate disposed therein anda water content of no more than about 10%, for example no more thanabout 5%, such that the lens covering has a very high Dk exceeding 150,and the silicone lens comprising silicate can be treated to provide awettable surface. The lens may comprise hydrogel, for example siliconehydrogel, and can be formed with a water content within a range fromabout 5% to about 35% and a modulus within a range from about 4 to about20 MPa, such that the covering conforms at least partially to theablated stroma.

The covering may comprise silicone or silicone hydrogel having a lowionoporosity such that covering seals to the cornea. For example,covering may comprise silicone hydrogel comprising a low ionpermeability, and the range of water can be from about 5% to about 35%,such that the Dk is 100 or more. The low ion permeability may comprisean Ionoton Ion Permeability Coefficient of no more than about 0.25×10-3cm2/sec so as to seal the cornea, for example no more than about0.08×10-3 cm2/sec. The low ion permeability comprises an Ionoton IonPermeability Coefficient of no more than about 2.6×10-6 mm2/min to sealthe cornea, for example no more than about 1.5×10-6 mm2/min.

The covering 100 may comprise a wettable surface coating 134 disposed onat least the upper side of the covering, such that the tear film of thepatient is smooth over the covering and the patient can see. Thewettable surface coating may comprise a lubricious coating for patientcomfort, for example to lubricate the eye when the patient blinks. Thewettable coating may comprise a contact angle no more than about 80degrees. For example, the coating may comprise a contact angle no morethan about 70 degrees, and the contact angle can be within a range fromabout 55 to 65 degrees to provide a surface with a smooth tear layer forvision. For example, the wettable coating can be disposed of both anupper surface and a lower surface of the covering. Alternatively, thelower surface may comprise a hydrophobic surface material and the lowerhydrophobic surface may comprise the inner portion 110 and the outerportion 120. At least the outer portion 120 may comprise a lower surfacecomposed of a sticky, tacky material, for example a hydrophobicmaterial. The inner portion may also comprise the lower surfacecomprised of the sticky, tacky, hydrophobic material. The upper surfacemay comprise the wettable coating extending over at least the innerportion 110.

The wettable coating may comprise one or more of many materials. Forexample, the wettable coating may comprise polyethylene glycol (PEG),and the PEG coating can be disposed on Parylene™. Alternatively, thewettable coating may comprise a plasma coating, and the plasma coatingcomprise a luminous chemical vapor deposition (LCVD) film. For example,the plasma coating comprises at least one of ahydrocarbon, for exampleCH4, O2 or fluorine containing hydrocarbon, for example CF4 coating.Alternatively or in combination, the wettable coating may comprise apolyethylene glycol (PEG) coating or 2-hydroxyethylmethacrylate (HEMA).For example, the wettable coating may comprise HEMA disposed on aParylene™ coating, or the wettable coating may compriseN-vinylpyrrolidone (NVP) disposed on a Parylene™ coating.

The covering 100 may comprise a lower surface corresponding to one ormore of many suitable shapes to fit the covering to the cornea. Forexample, the lower surface of the covering may correspond to base radiusof curvature. With post ablation corneas, the covering may conformsubstantially to the cornea. The covering may comprise a second curve incombination with a first curve, such that the lower surface comprises abicurve surface. Alternatively, the lower surface may correspond to anaspheric surface. For example, an aspheric surface may comprise anoblate shape and conic constant to fit a post PRK eye. Also, it may behelpful to fit the covering to the cornea, for example with selection ofone covering from a plurality of sizes.

FIG. 1A shows the covering 100 having the thickness 108 of the outerportion sized such that the outer portion can conform to the epithelium.The thickness of the outer portion can be substantially constant, or mayvary as described herein below.

FIG. 1A1 shows covering 100 positioned on an eye and blinking of theeye. An upper lid and a lower lid can blink over the eye. Work inrelation to embodiments suggests that the upper lid can exert a downwardmovement 20 and that the lower lid can exert an upper movement 22 on theeye. The downward movement 20 can be greater than the upper movement 22.The wettable coating material as described herein can decrease force andmovement transferred from the lids to the covering so as to inhibitmotion of the covering. The downward movement 20 greater than the upwardmovement 22 can affect epithelial growth near the perimeter of covering100.

FIG. 1B1 shows covering 100 as in FIG. 1-2A prior to placement on thecornea. The covering 100 may comprise a base radius R1 of curvature, andthe base radius of curvature may be slightly shorter than the ablatedcornea such that the covering can be steeper than the cornea prior toplacement on the cornea. The covering 100 comprises a firstconfiguration 100C1 prior to placement on the cornea.

The base radius R1 can be sized to the cornea in many ways. For example,base radius R1 may have a radius corresponding to the outer unablatedportion of the cornea. Alternatively or in combination, the base radiusR1 may have a radius corresponding to the post ablated eye.

The covering 100 may comprise a modulus within a range from about 4 MPato about 20 MPa, such that central portion can conform at leastpartially to the ablated stroma and so that the covering can smoothcorneal irregularities and stromal irregularities of the ablated cornea.The covering may comprise an elastomeric stretchable material such thatthe covering can stretch to fit the cornea, for example. The coveringhaving the modulus within a range from about 4 MPa to about 20 MPa canbe formed in many ways as described herein. For example, the coveringmay comprise a single piece of material having a substantially uniformthickness extending across the ablated cornea and at least a portion ofthe unablated cornea, and the single piece of material may comprise anelastic material such as a silicone elastomer or a hydrogel.Alternatively, the covering may comprise a single piece of materialhaving a non-uniform thickness extending across the ablated cornea andat least a portion of the unablated cornea. The covering can be shapedin many ways and may comprise a single piece of one material, or maycomprise a single piece composed to two similar materials, or maycomprise a plurality of materials joined together.

The covering 100 may comprise one or more outer portions extendingoutside the inner central portion, and these outer portions may seal thecornea when the inner portion conforms at least partially to the ablatedstroma. For example, the covering 100 may comprise outer portionadditional shapes disposed outward from a central portion as describedherein. For example, the covering may comprise a bicurve having a secondradius of curvature disposed peripheral to the inner radius R1 ofcurvature to fit the unablated portion of the cornea. For example, thesecond and outer radius of curvature may comprise a shorter radius ofcurvature when the central portion is treated for myopia. The coveringmay comprise a third radius of curvature longer than the second radiusof curvature so as to fit the sclera under the conjunctiva. The coveringmay comprise an oblate shape to fit the ablated and non-ablated portionsof the cornea, and the covering may extend over the sclera with an outerportion, for example.

FIG. 1B2 shows the covering as in FIG. 1B1 conforming to ablated stromaltissue and smoothing the epithelium over the ablated stroma. The corneacomprises an ablated surface 20 to correct vision that may have acorresponding radius of curvature, for example radius R2. The ablatedprofile 20 may comprise additional, alternative, or combinational shapeswith those corresponding to radius R2, such as aberrations ablated intothe cornea to correct aberrations of the eye and astigmatism ablatedinto the cornea, and the inner portion 110 of covering 100 can conformto these ablated profiles of the cornea such that the patient canreceive the benefit of the ablative vision correction when the coveringis positioned on the cornea. For example, the cornea ablation profile 20may correspond to radius of curvature R2, and the inner portion 110 canflatten from configuration 100C1 corresponding to radius of curvature R1prior to placement to a second configuration 100C2 correspondingsubstantially to the ablated profile 20, such the patient can see withthe benefit of ablation profile 20. For example, the secondconfiguration 100C2 can comprise a conforming radius of curvature R12that corresponds substantially to radius of curvature R2. The profilecorresponding to the first configuration 100C1 of the covering 100 isshown positioned over cornea 10 to illustrate the change in profile ofthe covering from configuration 100C1 prior to placement to conformingsecond configuration 100C2 of the covering 100 when positioned on thecornea.

The conformable covering 100 comprises sufficient rigidity so as tosmooth the epithelium when covering 100 is positioned on the cornea overthe ablation profile 20. The epithelium comprises a peripheral thickness12T that may correspond substantially to a thickness of the epitheliumprior to debridement of the epithelium to ablate the cornea. Theepithelium also comprises regenerating epithelium 12R disposed over theablation profile 20. The covering 100 can smooth the epithelium 12R whenconforming to the cornea in the second configuration 100C2. For example,irregularities 12I of the regenerating epithelium 12R disposed over theablation can be smoothed when the epithelium regenerates along the innerportion of covering 100, such that the irregularities 12I of theregenerating epithelium 12R are thinner than the thickness 12T of theperipheral epithelium.

Work in relation to the embodiments as described herein indicates thatan at least partially conformable covering having a modulus within arange from about 4 MPa to about 20 MPa can conform at least partially tothe ablated stroma and smooth irregularities of the epithelium andstroma so as to improve vision as described herein. The covering havingthe modulus within the range from about 4 MPa to about 20 MPa can beformed in many ways as described herein.

The conformable covering 100 may comprise a perimeter 120P with rigiditysufficient to indent the epithelium along at least a portion of theperimeter so as to seal the cornea with seal 100S. The portion 12C ofthe epithelium 12 can extend over the perimeter 120P of the covering100.

FIG. 1B2A shows a covering as in FIG. 1B2 forming an indentation 12IT inthe epithelium such that the epithelium 12 extends over at least aportion of the perimeter 120P of the covering. The covering formsindentation 12IT in the epithelium such that the epithelium comprises anindentation thickness 12T that is less than an outer thickness of theepithelium 12. The indentation of the epithelium with the covering canhelp to seal the cornea with the perimeter.

FIG. 1B2B shows a covering as in FIG. 1B2 forming indentation 12IT inthe epithelium. The covering forms indentation 12IT in the epitheliumsuch that the epithelium comprises an indentation thickness 12T that isless than an outer thickness of the epithelium 12T. The indentation ofthe epithelium with the covering can help to seal the cornea with theperimeter.

Work in relation to embodiments described herein suggests theindentation of the covering can vary radially around the eye of thepatient, in accordance with orientation of the covering on the eye whenthe covering comprises a substantially constant rigidity of the outerportion, for example a substantially constant rigidity around theperimeter. The inferior portion of the covering may comprise a greateramount of epithelial covering over the perimeter than the superiorportion of the covering. For example, FIG. 1B2A may correspond to afirst portion of covering 100 at an inferior location of the cornea andFIG. 1B2B may correspond to a second portion of the covering at asuperior location of the cornea. Work in relation to embodiments alsosuggests that there may be variability in covering of the perimeter withthe epithelium between the nasal portion of the perimeter, and thetemporal portion of the perimeter, although both the nasal and temporallocations can comprise covering intermediate and between the moreextensive covering of the inferior portion and the less extensivecovering of the superior portion of the perimeter.

FIG. 1B2C shows a covering abutting the cornea to seal the corneawithout forming a substantial indentation in the epithelium. Thecovering may comprise a chamfer to contact and seal the cornea. Therigidity of the outer portion can be determined based on the thicknessof the outer portion of the covering, hardness of the material, andchamfer angle so as to contact the epithelium to seal the cornea withoutsubstantial deformation of the epithelium.

The covering may comprise a non-uniform rigidity around the outerportion of the covering comprising the perimeter. For example, thecovering may comprise a superior portion corresponding to a superiorlocation on the cornea and an inferior portion corresponding to aninferior location on the cornea. The superior portion may comprise arigidity less than the inferior portion. For example, the superiorportion may comprise the rigidity less than the inferior portion, suchthat deformation of the epithelium is inhibited when the perimeter abutsthe cornea is sealed. Alternatively, the superior portion may comprisethe rigidity less than the inferior portion such the deformation of theepithelium with the covering comprises a substantially constant amountaround the perimeter, for example a deformation of no more than about 10um, for example 5 um.

FIG. 1C shows a therapeutic covering as in FIG. 1-2A comprising acovering molded with a homogeneous material, in which the outer portioncomprises a thickness configured to conform with the cornea and in whichthe inner portion 110 comprises thickness configured to smooth theepithelium and conform to the ablated profile 20. The outer portion 120may comprise a thickness of no more than about 100 microns. For example,the outer portion 120 may comprise a thickness of about 50 microns atthe boundary with the inner portion 110, and linearly taper from 50microns at the boundary with the inner portion to about 20 microns atthe periphery of the outer portion 120. The inner portion 110 maycomprise a thickness of no more than about 250 microns, for example nomore than about 200 microns. For example, the inner portion may comprisea thickness of about 100 microns. For example, the thickness of each ofthe inner portion and the outer portion may comprise no more than about50 microns so as to provide substantial oxygen transport and epithelialregeneration. Many materials can be used as described herein, and thecovering may comprise one or more materials. For example, the coveringmay comprise a single piece of material such as silicone having a watercontent within a range from about 0.1% to about 10%, for example no morethan about 1%, and a hardness Shore A durometer parameter within a rangefrom about 5 to about 90, for example within a range from about 40 toabout 85.

FIG. 1C1 shows a covering 100 having an inner portion 110 comprising aninner thickness and an inner material 110M and an outer portion 120comprising an outer thickness and an outer material 120M, in which theinner thickness is greater than the outer thickness. The inner material110M may comprise many materials and may comprise an optically clearsilicone, for example silicone with resin. The inner material maycomprise silicone positioned in a mold with the outer portion 120 formedaround the inner portion. The inner portion may comprise a hardnesssimilar to the outer portion. The outer material 120M of the outerportion 120 may comprise a material similar to the inner portion. Forexample, the outer material 120M may comprise silicone and the innermaterial 110M may comprise silicone. This use of similar materials onthe inner and outer portions can improve adhesion of the inner portionto the outer portion. The outer material 120M may extend along the innerportion 110, for example along the underside of the inner portion 110,such that the inner material 110M is held in a pocket of the outermaterial 120M. Alternatively, the inner material 110M may extendsubstantially across the thickness of the inner portion 110, such thatthe outer material 120M comprises a substantially annular shape with theinner material 110M comprising a disc shaped portion disposed within theannulus and extending substantially from the upper surface coating tothe lower surface coating when present.

FIG. 1C1A shows a covering as in FIG. 1C1 adhered to the cornea with asmooth upper surface, and a lower surface conforming to irregularity ofthe cornea, for example an irregularity comprising a central island 10CIof the ablated stroma. The central island 10CI may comprise an outwardprotrusion in the ablated profile of the stroma at least about 1 micronoutward and about 2.5 mm across, for example. The upper surface maycomprise a substantially rigid material for vision correction, and thelower surface may comprise a soft material so as to deflect toirregularities of the cornea when the upper surface provides opticalcorrection. For example, the lower surface may comprise an indentation110I when positioned on the irregularity of the cornea. Although thelower surface comprising the soft material can deflect to correspond tothe ablation profile 20, the upper surface comprising the rigid materialmay comprise a predetermined curvature selected by a health careprovider so as to fit the ablation profile and correspond to therefractive correction of the patient so as to provide vision correction.

FIG. 1C2 shows a covering as in FIGS. 1-2A to 1B2 having inner portion110 comprising an inner thickness and inner material 110M and outerportion 120 comprising an outer thickness and outer material 120M, inwhich the inner thickness can be greater than the outer thickness andthe outer material 120M extends around the inner material 110M. Thecovering 100 may comprise at least a bicurve covering having at least asecond radius R1B. The inner portion 110M may comprise three layers ofmaterial, a first layer 100L1 of a first material 110M1, a second layer100L2 of a second material 110M2 and a third layer 100L3 of a thirdmaterial 110M3. The second material 110M2 may comprise a rigid material,for example one or more of a rigid gas permeable material, a rigidsilicone, or a rigid silicon acrylate. The first material 110M1 and thethird material 110M3 may comprise a soft material, for example a softelastomer or soft hydrogel such as one or more of a soft optically clearsilicone or a soft silicone hydrogel. The first material, the thirdmaterial, and the outer material 120M may comprise similar materials,such that the second layer of rigid material 110M2 is encapsulated withthe first soft material 110M1, the third soft material 110M3 and on theperimeter with the soft outer material 120M. In many embodiments, thesecond rigid material 110M2 comprises a material similar to each of thefirst material 110M1, the third material 110M3 and the outer material120M, for example each may comprise silicone, such that thecorresponding portions of the covering 100 can be bonded together withthe silicone similar to silicone elastomer material, for example. Inmany embodiments, the covering 100 can be formed in a mold with rigidsecond material 110M2 placed in the mold and encapsulated within asingle piece of material comprising first material 110M1, third material110M3 and outer material 120M, such that first material 110M1, thirdmaterial 110M3 and outer material 120M comprise substantially the samematerial, for example silicone elastomer. The rigid second material110M2 may comprise silicone bonded to each of first material 110M1,third material 110M3 and the outer material 120M, for example withcuring such that first material 110M1, third material 110M3 and outermaterial 120M comprise the same soft silicone material bonded to thesecond material 110M2 comprising rigid silicone.

The soft material comprising soft outer portion 120 composed of softmaterial 120M, first layer 100L1 composed of soft material 110M1 andthird layer 100L3 composed of soft material 120M3 can provide improvedcomfort and healing for the patient. The soft material can deflect, bendor indent so as to conform at least partially to the tissue of the eyewhen the rigid portion comprising rigid material 110M2 corrects visionof the patient. The dimension 102 across inner portion 110 can be sizedto substantially cover the ablation zone and slightly smaller than theablation dimensions, such as ablation diameter 20D, so that theepithelium can grow inward and contact the layer 100L1110L1 of softfirst material 110M1 without substantial disruption from the rigidmaterial 120M2 when the inner portion 110M corrects vision with thelayer of rigid material 110M2. The eyelid can also move over the thirdlayer 100L3 for improved comfort. The soft first material 110M1 and softthird material 110M3 may comprise soft elastomer or soft hydrogel, forexample, and may each comprise the same material so as to encapsulatethe second layer 100L2 of rigid second material 110M2.

The soft material comprising soft outer portion 120 composed of softmaterial 120M, first layer 100L1 composed of soft material 110M1 andthird layer 100L3 composed of soft material 110M3 can have a moduluswithin a range from about 1 to 20 MPa, for example within a range fromabout 1 to 5 MPa.

The material inner material 120M and 110M2 of second layer 100L2 canhave a modulus within a range from about 5 to about 35 or more, forexample as set forth in Table A below. For example, when material 120Mcomprises silicone elastomer or layer 100L2 of material 110M2 comprisessilicone elastomer, the modulus can be within a range from about 5 toabout 35 MPa, for example within a range from about 20 to about 35 MPa.

The layers of covering 100 can comprise dimensions so as to providetherapeutic benefit when placed on eye 2. The thickness of layer 100L1can be from about 5 um to about 50 um, for example, within a range fromabout 10-30 um, such that the layer 100L1 can provide a soft at leastpartially conformable material to receive the lens. The middle layer100L2 can be from about 20 um to about 150 um, for example, and material110M2 can have a modulus greater than first material 110M1 of firstlayer 100L1, so as to deflect the epithelium of the eye when the middlelayer is deflected. The third layer 100L3 can be within a range fromabout 5 um to 50 um, for example within a range from about 10 um toabout 30 um, and can cover second layer 100L2 so as to retain the secondlayer in the inner portion 110 of the covering 100.

FIG. 1C2A shows a covering as in FIG. 1C1 placed on the cornea with asmooth upper surface and a lower surface conforming to irregularity ofthe cornea near the edge of the ablation. As the epithelium can be about50 um thick, in many embodiments the dimension 102 is sized so as tocover substantially the ablated cornea for vision correction and smallerthan the ablation zone, such that the outer portion 120 can conform atleast partially to the epithelium. The outer portion 120 may extend tothe sclera, and comprise a tri-curve covering 100 as described herein,with the inner portion 110 having first layer 100L1 of first material110M1, second layer 100L2 of second material 110M2, and third layer100L3 of third material 110M3.

FIG. 1C2A1 shows a covering having a layer of hydrogel material on aposterior surface of the covering. The covering 100 may comprise awettable surface coating 134 disposed on at least the upper side of thecovering as described herein. The layer of hydrogel material maycomprise an inner portion of the layer of hydrogel material 110MHG andan outer portion of the layer of hydrogel material 120MHG. The layer ofhydrogel material extends to the fenestration so as to couple thehydrogel material to the fenestration. The hydrogel material can becoupled to the fenestration in many ways. For example, the layer ofhydrogel material may cover the fenestration, or the fenestration 100Fmay extend through the hydrogel material. The fenestration 100Fextending through the layer of hydrogel material can encourage pumpingof the tear liquid as described herein. Alternatively or in combination,the layer of hydrogel material covering a posterior surface of thefenestration 100F to couple the fenestration 100F to the hydrogel layermay encourage movement of a therapeutic agent along the hydrogel layertoward a central portion of the cornea for example. The hydrogel mayextend along a deflectable portion of the covering so as to exert atleast some pressure on the hydrogel layer to encourage movement of oneor more of tear liquid or the therapeutic agent along the hydrogel layerwhen the patient blinks, for example.

The hydrogel layer as described herein may encourage regeneration of theepithelium and may provide a soft surface to contact the epitheliumregenerating over the ablation so as to encourage epithelialregeneration under the optical component as described herein, and theoptical component can resist deformation so as to protect the epitheliumand provide an environment to encourage regeneration of the epithelium.

The hydrogel material may comprise one or more of the hydrogel materialsas described herein. The hydrogel material extending along the lowersurface can increase comfort of the covering when placed on the eye. Thehydrogel material may comprise a substantially uniform thickness withina range from about 1 um to about 100 um, for example from about 2 um toabout 50 um and in many embodiments within a range from about 5 um toabout 20 um. The hydrogel material extending along the posterior surfacemay comprise on or more of the hydrogel materials as described hereincombined with one or more of materials 110M, 110M1, 110M2, 110M3 or 120Mas described herein. For example the one or more of materials 110M,110M1, 110M2, 110M3 or 120M may comprise silicone such as siliconeelastomer comprising siloxane, and the hydrogel may comprise a hydrogelsuch as silicone hydrogel material as described herein.

FIG. 1C2A shows a covering having a layer of hydrogel material on aposterior surface of the covering. The covering 100 may comprise awettable surface coating 134 disposed on at least the upper side of thecovering as described herein. The layer of hydrogel material maycomprise an inner portion of the layer of hydrogel material 110MHG andan outer portion of the layer of hydrogel material 120MHG. The layer ofhydrogel material extends to the fenestration so as to couple thehydrogel material to the fenestration. The hydrogel material can becoupled to the fenestration in many ways. For example, the layer ofhydrogel material may cover the fenestration, or the fenestration 100Fmay extend through the hydrogel material. The fenestration 100Fextending through the layer of hydrogel material can encourage pumpingof the tear liquid as described herein. Alternatively or in combination,the layer of hydrogel material covering a posterior surface of thefenestration 100F to couple the fenestration 100F to the hydrogel layermay encourage movement of a therapeutic agent along the hydrogel layertoward a central portion of the cornea for example. The hydrogel mayextend along a deflectable portion of the covering so as to exert atleast some pressure on the hydrogel layer to encourage movement of oneor more of tear liquid or the therapeutic agent along the hydrogel layerwhen the patient blinks, for example.

The hydrogel layer as described herein may encourage regeneration of theepithelium and may provide a soft surface to contact the epitheliumregenerating over the ablation so as to encourage epithelialregeneration under the optical component as described herein, and theoptical component can resist deformation so as to protect the epitheliumand provide an environment to encourage regeneration of the epithelium.

The hydrogel material may comprise one or more of the hydrogel materialsas described herein. The hydrogel material extending along the lowersurface can increase comfort of the covering when placed on the eye. Thehydrogel material may comprise a substantially uniform thickness withina range from about 1 um to about 100 um, for example from about 2 um toabout 50 um and in many embodiments within a range from about 5 um toabout 20 um. The hydrogel material extending along the posterior surfacemay comprise on or more of the hydrogel materials as described hereincombined with one or more of materials 110M, 110M1, 110M2, 110M3 or 120Mas described herein. For example the one or more of materials 110M,110M1, 110M2, 110M3 or 120M may comprise silicone such as siliconeelastomer comprising siloxane, and the hydrogel may comprise a hydrogelsuch as silicone hydrogel material as described herein.

FIG. 1C2B shows a covering having a layer of hydrogel material on aposterior surface of the covering extending less than a maximum distanceacross the covering such that end portions of the covering areconfigured to engage the epithelium of the eye away from the hydrogellayer and inhibit movement of the covering when placed on the eye. Inmany embodiments, the material 120M can couple to the surface of theeye, for example the epithelium so as to inhibit movement of thecovering. The material 120M may comprise a sticky tacky hydrophobicmaterial such as silicone to engage the epithelium to inhibit movement,and the material 120M may be coated with one or more coatings asdescribed herein, for example with vapor deposition. The hydrogelmaterial can be coupled to the fenestration in many ways. For example,the layer of hydrogel material may cover the fenestration, or thefenestration 100F may extend through the hydrogel material.

FIG. 1C2C shows a covering 100 having an annular layer of hydrogelmaterial 120MHG on a posterior surface of the covering such that aninner portion of the covering contacts the cornea away from the hydrogellayer and an outer portion of the covering contacts the cornea away fromthe covering when placed on the eye. Work in relation to embodimentssuggests that the annular hydrogel layer can provide an environment toencourage growth of the epithelium along the posterior surface of innermaterial 110M1 as described herein, and the lower surface of material110M1 can be coated with a material having a thickness less than thehydrogel, for example.

FIG. 1C3 shows a shows a covering having a tricurve profile to fitsclera with slopes of the curved profiles aligned so as to inhibitridges at the boundaries of the curved portions as in FIG. 1B2 andhaving a layer of hydrogel material 120MHG on a lower surface. Thehydrogel material 120M may extend substantially across the posteriorsurface of the covering. The covering may extend along the lower surfacea distance less than a distance across the covering so as to provide aportion of the covering without the hydrogel to engage the eye, forexample the epithelium of the eye that may comprise one or more of thecorneal epithelium or the conjunctival epithelium. Alternatively, thecovering may extend substantially along the posterior surface of thecovering corresponding to the distance across the covering so as toprovide the hydrogel covering over the outer portion of the coveringthat engages the eye.

FIG. 1C4 shows a plan view covering having a tricurve profile to fit thecornea, limbus and sclera with slopes of the curved profiles aligned soas to inhibit ridges at the boundaries of the curved portions and havinga hydrogel material on a lower surface extending less than a maximumdistance across the covering to engage the conjunctiva with the coveringaway from the hydrogel material. Alternatively, the covering may extendsubstantially along the posterior surface of the covering correspondingto the distance across the covering so as to provide the hydrogelcovering over the outer portion of the covering that engages the eye.The hydrogel covering may comprise an annular shape extending along thelower surface as described herein.

FIG. 105 shows a fenestration 100F having a posterior end 100FPE coveredwith a layer of hydrogel material 29MHG extending along the posteriorsurface of the covering 100, in accordance with embodiments of thepresent invention;

FIG. 106 shows a fenestration 100F extending through a layer of hydrogelmaterial 120MHG extending along the posterior surface of the covering100, in accordance with embodiments of the present invention;

FIG. 1D shows atherapeutic covering 100 comprising a first innermaterial 110M and a second outer material 120M, in which the outerportion 120 comprises a hardness configured to conform with epitheliumof the cornea and in which the inner portion 110 comprises secondhardness configured to smooth the epithelium and conform to the ablatedprofile 20. The outer material 120M may comprise many materials asherein. The Shore A hardness of each of the inner portion and the outerportion can be within a range from about 5 to about 90. For example, theouter material 120M may comprise silicone having a hardness Shore Adurometer parameter from about 20 to about 50, for example from about 20to about 40, and the inner material 110M may comprise silicone having ahardness durometer parameter from about 40 to about 90, for example fromabout 50 to about 90. The outer portion comprises a perimeter 120P, andthe perimeter may comprise a peripheral and circumferential edgestructure to abut the epithelium to form the seal with the epithelium,for example when the base radius of the covering is less than thecornea. The peripheral and circumferential edge structure can be shapedin many ways to define an edge extending around the perimeter to abutthe epithelium, for example with one or more of a taper of the edgeportion extending to the perimeter, a bevel of the edge portionextending to the perimeter or a chamfer of the edge portion extending tothe perimeter. The inner portion 110 may comprise inner thickness andinner material 110M and the outer portion 120 may comprise an outerthickness and outer material 120M, in which the inner thickness issubstantially similar to the outer thickness.

The peripheral edge structure to abut the epithelium can be used withmany configurations of the inner portion as described herein. Forexample, the inner portion may comprise an RGP lens material having alower rigid surface to contact and smooth the cornea and an upper rigidoptical surface. Alternatively, the inner portion may conform to thecornea as described herein. The outer portion may comprise a skirt, andthe skirt may comprise the peripheral edge structure to abut and sealthe cornea, such as the chamfer. The rigidity of the outer portioncomprising the edge structure can be determined to seal the cornea withone or more of hardness and thickness, as described herein.

FIGS. 1E and 1F show top and side views, respectively, of covering 100comprising inner portion 110, outer portion 120, and a peripheral rimportion 140 disposed around outer portion 120. The peripheral portion140 can be more rigid than outer portion 120. Work in relation toembodiments suggests that in some instances the lower sticky, tackysurface of outer portion 120 can stick to itself during deployment ontothe eye, and the peripheral portion 140 can improve handling when thecovering is placed on the eye. The covering may comprise a single pieceof material or may comprise multiple pieces adhered together, forexample molded together. For example, the covering may comprise an innerthickness of inner portion 110 and an outer thickness of outer portion120, in which the inner thickness is greater than the outer thickness.The peripheral portion 140 may comprise a thickness, and the thicknessof the peripheral portion 140 can be greater than the thickness of outerportion 120 such that the peripheral portion 140 is more rigid than theouter portion 120. The thickness of the inner portion 110 and thethickness of the peripheral portion 140 can be substantially similar,and these portions may comprise substantially the same thickness andrigidity.

FIG. 1G shows covering 100 comprising inner portion 110 and outerportion 120, such that outer portion 120 comprises a taper 120T ofthickness 108 extending between the perimeter of the inner portion 110and the perimeter of the outer portion 120. The taper may comprise asubstantially linear change in thickness 108 extending between theperimeter of the inner portion and the perimeter of the outer portion.

FIG. 1G1 shows a covering 100 comprising inner portion 110 and an outerportion 120 comprising the taper as in FIG. 1G, and an outer rim orflange 120F of substantially uniform thickness peripheral to the taper120T. The outer taper may extend from the dimension across 102 of theinner portion 110 to the dimension across 154A that is less than thedimension across 104 of the outer portion. The rim of substantiallyuniform thickness may comprise an annular shape having a thicknesswithin a range from about 10 um thick to about 40 um thick, and maycomprise a width 154B within a range from about 0.05 to about 0.8 mm,for example about 0.5 mm. The rim, for example flange 120F, may comprisea thickness of no more than about 50 um, such that the flange comprisesa thickness no more than the epithelium.

The covering 100 can be dimensioned in many ways. The total diameteracross can be from about 6 mm to about 12 mm, for example about 10 mm.The inner portion may comprise a diameter within a range from about 4 mmto 8 mm, for example about 6 mm. The annular rim comprising flange 120Fcan extend around the perimeter of the covering with a thickness ofabout within a range from about 5 um to about 50 um, for example about35 um. The annular rim comprising flange 120F may comprise an innerdiameter of within a range from about 5 mm to about 11 mm, for exampleabout 9 mm and an outer diameter within a range from about 6 mm to about12 mm, for example about 10 mm and corresponding to the perimeter of thecovering. The annular rim may comprise a width of within a range fromabout 0.1 mm to about 1 mm, for example 0.5 mm, extendingcircumferentially around the covering. The outer portion 120 maycomprise the rim with flange 120F and a taper 120T that extended frominner portion 110 to the rim comprising perimeter 120P. The taper inthickness can be substantially uniform between the outer diameter of theinner portion and the inner diameter of the rim, and the boundaries ofthe taper can be rounded and smoothed near the inner portion and therim. The central portion may comprise a substantially uniform thicknesswithin a range from about 50 um to about 150 um, for example about 50um. The base radius of curvature of the lower surface of the coveringcan be within a range from about 7 mm to about 8 mm. The lower surfacemay comprise an aspheric surface or a bicurve surface and combinationsthereof. The upper surface of the covering can comprise a radius ofcurvature along the inner portion within about 0.1 mm curvature of thelower surface, such that the covering is substantially uniform with nosubstantial refractive power, for example refractive power within about+/−1D.

FIGS. 1G1A to 1G1H show a covering as in FIG. 1G1 and dimensionssuitable for use in accordance with embodiments as described herein suchas with experiments, clinical studies and patient treatment. FIG. 1G1Ashows an isometric view of covering 100 having the inner portion 110,the outer portion 120, the taper 120T and rim comprising flange 120F.FIG. 1G1B shows a bottom view of covering 100. FIG. 1G1C shows a sideview of the covering 100. FIG. 1G1D shows a top view of the covering100. FIG. 1G1E shows a side cross sectional view of covering 100 alongsection D-D. FIG. 1G1F shows detail C of cross-section D-D, includingthe radius of curvature R1 of the lower surface of the inner portion110, and the upper radius of curvature Rupper of the inner portion 110.The upper radius of curvature Rupper may correspond substantially to thelower radius of curvature R1 prior to placement on the eye, for exampleto within about +/−1 D of optical power, such that the inner portion 110prior to placement may comprise no substantial optical power. Detail Cshows a side cross sectional view of covering 100 of the inner portion.FIG. 1G1G shows detail B of cross-section D-D. Detail B shows a sidecross sectional view of the rim comprising flange 120F. The flange 120Fhas a thickness 109. Flange 120F may comprise a taper extending along awidth 102FW, for example from a first thickness 109A of about 35 um tosecond thickness 109B of about 25 um extending along width 120FW nearthe chamfer. Flange 120F comprises a chamfered edge 120FE to contact thecornea or conjunctiva along perimeter 120P of the covering.

FIG. 1H1 shows spatial frequency and elevation smoothing of anepithelial irregularity 12I transferred to a front surface 110U ofcovering 100 as in FIG. 1-2A. The regenerating epithelium 12R comprisesan irregularity 12I. The covering 100 conforms substantially to theshape ablated in the stroma when positioned on the eye as noted above.The covering 100 comprises a rigidity so as to conform substantially tothe ablation profile 20 over about at least about 3 to 4 mm of theablated stroma such that the patient can see and receive opticalcorrection with the ablated surface. The regenerating epitheliumcomprises a thickness profile 12RP that includes irregularity 12I. Theconformable covering comprises a thickness profile of thickness 106 thatencompasses a deformation thickness over the irregularity 106D. Thethickness of the covering can vary over the epithelium to smooth theirregularity transmitted to the front surface of the covering so as toimprove patient vision consistent with the ablation profile 20 when thecovering conforms to the ablation profile 20. For example thickness 106Dover the irregularity can be less than thickness 106 away from theirregularity. The irregularity may comprise an indentation and thecovering may be thinner over the indentation. The silicone elastomer andhydrogel materials as described can be at least somewhat compressible soas to conform at least partially to the cornea and form an indentationso as to receive a portion of the cornea comprising one or more ofepithelium or ablated stroma and decrease aberrations.

Experimental studies of optical coherence tomography (hereinafter “OCT”)images and Pentacam™ images and topography images, noted below, indicatethat the thickness of the inner portion of the covering 100 can vary soas to decrease optical aberrations along the upper surface when thecovering is adhered to the cornea. This variation in thickness can berelated to one or more of stretching of the covering over theirregularity or compression of the covering over the irregularity.

The irregularities of the epithelium generally comprise spatialfrequencies that are greater than the spatial frequencies of the visioncorrecting portion of the ablation. The covering can provide spatialfiltering of the frequencies of the underlying surface so as to inhibitrelatively higher spatial frequencies of epithelial irregularities andpass relatively lower spatial frequencies corresponding to visioncorrection, such as lower spatial frequencies corresponding to sphereand cylinder. The spatial frequencies ablation profile 20 that areuseful to correction vision can be lower than the spatial frequencies ofthe irregularities, and the spatial dimensions of the vision correctiongreater than the dimensions of the irregularities. For example, thespatial frequencies of the vision correction can correspond to periodsof oscillation less than the periods of oscillation of theirregularities.

FIG. 1H2 shows spatial frequency and elevation smoothing of theepithelial irregularity with a plot of relative height relative for theupper surface of the covering and the upper surface of the irregularity.The irregularity of the regenerating epithelium 12R may comprise aprofile height 12RPH and profile width 12RPW. The upper surface of thecovering may comprise a profile 110UP. The irregularity of the uppersurface corresponding comprises a width 110UPW and a height 110UPH.Height 110UPH is less than height 12RPH so as to correspond to smoothingof the irregularity. Width 110UPW is greater than width 12RPW so as tocorrespond to smoothing of the irregularity. Profile 110UP of the uppersurface of the covering corresponds to lower frequencies than profile12RP, such that the covering comprise a low pass spatial frequencyfilter. This can be seen with the Pentacam™ and topography data shownbelow in conjunction with OCT images showing that the covering andcornea conform without a substantially gap disposed therebetween.Alternatively or in combination, the covering can smooth the cornea whena gap is present, for example when a portion of the cornea is smoothedwith contact to the covering and the gap provides an environment for theepithelium to grow smoothly over the ablation.

Based on the teachings described herein, a person of ordinary skill inthe art can conduct studies to determine empirically the rigidity of theinner portion so as to pass substantially vision correction spatialfrequencies of the ablation to the upper surface of the covering andinhibit spatial frequencies of the irregularities of the ablated stromaand epithelium, for example with Pentacam™ and topography studies asdescribed in the experimental section.

Work in relation to the embodiments as described herein indicates that acovering comprising a modulus within a range from about 4 MPa to about20 MPa can provide smoothing with low pass spatial frequency filteringas described with reference to FIGS. 1H1 and 1H2. The covering maycomprise an elastically stretchable material, for example an elastomeror a hydrogel, such that the lens can conform at least partially to theablated stroma and exert at least some pressure on the ablated stromaand epithelium when at least partially conformed so as to smoothirregularities of the epithelium and irregularities of the stroma. Thecovering can comprise a thickness and a hardness so as to provide thespatial frequency filtering to improve vision in post-PRK patients withthe modulus within the range from about 4 MPa to about 20 MPa. Forexample, the lens thickness can be increased to increase the modulus,decreased to decrease the modulus. The hardness of the material can beincreased to increase the modulus and decreased to decrease the modulus.The modulus within the range from about 4 MPa to about 20 MPa canattenuate substantially higher spatial frequencies corresponding toirregularities of the epithelium and stroma so as to smooth the highspatial frequencies corresponding to the irregularities that can degradevision, and can conform substantially to lower spatial frequencies thatcorrespond to the vision correction so as to pass the lower spatialfrequencies corresponding to vision correction so that the patient canexperience an improvement in vision when the epithelium regeneratesunder the covering. For example, the high spatial frequencies maycorrespond to frequencies greater than about ⅙ (0.17) cycles per mm, andthe low spatial frequencies may correspond to frequencies less thanabout ⅙ (0.17) cycles per mm. A person of ordinary skill in the art candetermine the modulus and corresponding spatial frequencies to attenuateand pass, in accordance with the teachings as described herein. Forexample, the modulus of the covering can be measured with known methodsand apparatus to measure the modulus of a contact lens, and measurementswith Pentacam™ images as described herein can be used to determine therelationship of the modulus of the measured lens coverings to smoothirregularities, conformation of the lens coverings to the ablation, andvision.

FIG. 1I1 shows an inhibition of transfer of a corneal irregularity to afront surface of a covering, for example one or more of a stromalirregularity or an epithelial irregularity. The front surface of thecovering comprises an optical surface for vision without substantiallytransfer of the irregularity to the front surface of the covering.

FIG. 1I2 shows elevation smoothing of the epithelial irregularity with aplot of height relative to a reference sphere for the upper surface ofthe covering and the upper surface of the irregularity. The plot shows asubstantially spherical front surface of the covering, such that thetransfer of the irregularity to the front surface is inhibited.

FIG. 1I3 shows a thickness profile of the covering as in FIG. 112 so asto smooth irregularities transferred to the front surface of thecovering. The thickness profile can vary in response to the underlyingsurface, for example with a decrease in thickness corresponding to anelevation in the surface profile of the cornea.

FIG. 1J1 shows covering 100 having a bicurve profile to fit an ablatedcornea. The bicurve profile may comprise an inner portion having a lowersurface comprising a radius of curvature R1 and an outer portion havinga radius of curvature R1B. The inner portion may comprise a radiusselected to fit approximately the post-ablated cornea, for example towithin about +/−2D. The outer portion may comprise the radius ofcurvature R1B sized to correspond to the outer unablated cornea, forexample to within about +/−2D. The covering may comprise an elasticmaterial with a modulus within a range from about 4 MPa to about 20 MPa,such that the covering can conform at least partially to the cornea andsmooth irregularities of the cornea as described herein. R1 can belonger than R1B, for example with PRK ablation to treat myopia. R1 canbe shorter than R2, for example with PRK ablation to threat hyperopia.

FIG. 1J2 shows covering 100 having an oblate profile to fit an ablatedcornea, for example a cornea ablated for myopia. The covering maycomprise an apical radius of curvature corresponding to R1 near a centerof the covering, and a peripheral radius of curvature, based on theconic constant of the oblate profile of the lower surface of covering100. Alternatively, the lower covering 100 may comprise a prolateellipsoid shape to fit a PRK ablation to treat hyperopia.

FIG. 1J3 shows covering 100 having a tricurve profile to fit sclera andan ablated cornea. The tricurve covering may comprise an inner portionwith an inner lower surface having radius of curvature R1 and an outerportion comprising an outer lower surface having radius of curvatureR1B, as described above. The covering may comprise a third portion 130disposed outside the outer portion and having a third radius ofcurvature R1C sized to fit the sclera and contact the conjunctivadisposed over the sclera. Work in relation to embodiments suggests thatcoupling to the sclera may improve alignment of the lens on the cornea.

The covering 100 having the tricurve profile may comprise dimensionssized to fit the cornea and sclera of the eye 2. The covering 100 havingthe tricurve profile may comprise an inner portion 110 and an outerportion 120 as described herein. The outer portion 120 may comprise thethird scleral portion 130S having curvature R1C shaped to fit the scleraof the eye, for example shaped so as to contact the conjunctiva of theeye such that the conjunctiva is located between the sclera and thescleral portion 130S. The inner portion 110 may comprise a dimension 102and the outer portion 120 may comprise a dimension 104 as describedherein. The covering 100 may comprise a sag height 105 extending betweenan upper location of the inner portion 110 and the outer boundary ofouter portion 120 shaped to fit the cornea. The third portion 130 maycomprise a dimension across 103.

The dimension 102, the dimension 104 and the dimension 103 can be sizedto the eye based on measurements of the eye. The dimension 103 maycorrespond to an annular region of the sclera extending from the limbusto the outer boundary of the third portion across a distance within arange from about 1 to 4 mm, for example within a range from about 1.5 to2 mm. The size of the limbus of the eye can be measured so as tocorrespond to dimension 104, for example, and can be within a range fromabout 11 to 13 mm. The ablation zone can correspond to dimension 102,and dimension 102 corresponding to the rigid inner portion can be sizedabout 0.5 to about 2 mm less than the dimension across the ablationzone, such that the soft outer portion 120 contacts the eye near theedge of the ablation and the epithelial debridement.

The radius of curvature R1C of portion 130 can be determined so as tofit the eye, and can be within a range from about 12 mm+/−3 mm. Theouter portion can be fit to within about +/−0.5 mm, for example towithin about +/−0.25 mm.

The dimensions of the covering 100 can be determined in many ways, forexample with topography measurements of the cornea and sclera. Thecorneal and scleral topography can be measured with many instruments,such as with the Orbscan™ topography system commercially available fromBausch and Lomb, and the Pentacam™ Scheimpflug camera systemcommercially available from Oculus. The ablation profile can be combinedwith the topography to determine the shape of the eye.

The dimensions of covering 100 can be sized to one or more of the corneaand sclera based on tolerances that may be determined clinically.

The outer portion 120 and the third portion 130 may comprise openingssuch as fenestrations as described herein, for example when the materialcomprises silicone.

The outer portion 120 and third portion 130 may comprise a hydrogelmaterial, for example a silicone hydrogel material, and the innerportion 110 may comprise the rigid material 110M, for example secondlayer 100L2 and second material 110M2 between first layer 100L1 of firstmaterial 110M1 and third layer 100L3 of third material 110M3 asdescribed herein.

As the tricurve covering may couple to the sclera so as to provideenvironment 100E to promote epithelial regeneration withoutsubstantially sealing the cornea, the outer portion 120 of the coveringand the third portion 130 of the covering may comprise substantiallywater permeable material, for example when the inner portion 110comprises the rigid material as described herein.

FIG. 1J4 shows covering 100 having a curved profile to fit sclera and anoblate profile to fit ablated cornea. The covering comprises the innerportion having the lower surface with the oblate profile having radiusof curvature R1 comprising an apical radius of curvature and radius ofcurvature RO, and an outer portion comprising a lower surface havingradius R1C to couple to the sclera as described herein. The apicalradius of curvature may comprise a first radius of curvature and theradius of curvature R0 may comprise a second radius of curvaturecorresponding to a conic constant of the oblate profile.

The portions of the coverings as described herein, for example the innerportion and the outer portion, may comprise a junction wherein a firstportion connects with a second portion, and the junction may have themodulus as described herein. The covering may comprise a contact lenshaving a central lens portion having a center stiffness of at leastabout 2 psi*mm2 coupled to an outer lenticular junction portion having alenticular junction stiffness of at least about 5 psi*mm2.

FIG. 1J5 shows a covering 100 having the tricurve profile to fit scleraand the ablated cornea similar to FIG. 1J3. The modulus and thickness ofthe sclera contacting portion can be configured in many ways to fit manyeyes with comfort and so as to resist movement of the inner portion 120.The modulus of sclera coupling portion 130 may be no more than about 5MPa and the thickness no more than about 200 um so as to stretchsubstantially for comfort and resist movement of the inner portion whenplaced on the sclera.

The dimension 103 of sclera contacting portion 130 may correspond to anannular region of the sclera extending from the limbus to the outerboundary of the third portion across a distance within a range fromabout 1 to 4 mm, such that the dimension 103 can be from about 12 mm toabout 16 mm, for example from about 14 mm to about 16 mm.

The radius of curvature R1C, thickness and modulus of the portion 130can be configured so as to fit the eye to resist movement of innerportion 120 and with comfort. The radius of curvature R1C can be sizedless than the radius of curvature of the sclera and conjunctiva. Forexample, the radius of curvature R1C can be no more than about 10 mm,for example no more than about 9 mm when the curvature of the scleralportion of the eye is at least about 12 mm for example. The thirdrelative rigidity may comprise no more than about 4E-5 Pa*m̂3 so as tostretch substantially for comfort and resist movement of the innerportion when the outer portion is placed on the sclera.

The thickness of the third portion having radius of curvature R1C canvary, for example from a thickness of about 200 um to a tapered edge.

FIG. 1J6 shows a tapered edge of the covering having a tricurve profileto fit sclera and an ablated cornea as in FIG. 1J5. The third portion130 may comprise a flange 120F having a narrowing taper extending adistance 120FW to a chamfer 120FE. The chamfer 120FE can be definedalong an outer rim where a first convexly curved lower surface joins asecond convexly curved upper surface. The convex surfaces along theouter rim allow the covering to slide along the conjunctiva and thenarrowing taper permits the third portion of the covering to stretchsubstantially and couple to the sclera and conjunctiva with decreasedresistance for comfort.

The dimensions of the covering 100 can be determined in many ways, forexample with topography measurements of the cornea and sclera. Thecorneal and scleral topography can be measured with many instruments,such as with the Orbscan™ topography system commercially available fromBausch and Lomb, and the Pentacam™ Scheimpflug camera systemcommercially available from Oculus. The ablation profile can be combinedwith the topography to determine the shape of the eye.

FIG. 1K shows covering 100 having inner portion 110 and outer portion120, and fenestrations 100F extending through the thickness of thecovering on the outer portion so as to pass a medicament when the corneais sealed. The medicament may comprise an anesthetic, an analgesic, orother medication, for example. The covering sealed to the cornea caninhibit the egress of the medicament toward the epithelial defect sothat reepithelialization is not delayed. For example, an anesthetic suchas proparacaine, lidocaine can be used to inhibit pain when theepithelium regenerates.

FIG. 1L shows fitting of a covering 100 to a cornea. The covering maycomprise a base curvature, for example first radius of curvature R1 ofinner portion 110 that may correspond to a radius of curvature when thecovering comprises first configuration 100C1 prior to placement on thecornea. The covering may comprise a second radius of curvature R1B. Theablated cornea may comprise a second radius of curvature R2. The outerunablated portion of the curvature may comprise a corneal radius ofcurvature RC. The second radius of R2 of the outer portion 120 can besized to fit the outer unablated portion of the cornea having radius ofcurvature RC, for example to within about +/−1D corresponding to withinabout +/−0.2 mm for RC of about 8 mm.

The first radius of curvature R1 can be greater than the ablated radiuscurvature R2 such that the curvature of the inner portion of thecovering is less than the curvature of the cornea. As the curvature isinversely related to the radius of curvature, the inner portion 110 hasa curvature less than the curvature of the ablation profile 20 of thecornea when the base radius of curvature R1 of the inner portion isgreater than the radius of curvature R2 of the ablated cornea. Thecovering having substantially uniform thickness as described herein withthe curvature less than the ablated cornea can correct visualaberrations that may be related to epithelial irregularity 12I, forexample so as to correct temporary myopia related to irregularity 12I.

Work in relation to embodiments indicates that environment 100E topromote epithelial regeneration can be enhanced when the curvature ofthe inner portion 110 is less than the curvature of the ablated corneacorresponding to radius R2. The epithelium 12 may comprise a thickness Textending between an anterior surface of the epithelium and a posteriorsurface of the epithelium, and the thickness T can vary across thesurface of the cornea. The base radius of curvature R1 sized greaterthan the radius of curvature R2 of the ablated profile 20 can defineenvironment 100E with a concave meniscus profile such that pressure nearthe boundary of inner portion 110 is decreased to encourage epithelialmigration inward as indicated by arrows 30 and pressure near a center ofinner portion 110 is increased so as to inhibit formation ofirregularity 12I and provide smooth regeneration of the epithelium. Forexample, the inner portion of the covering can have a curvaturecorresponding to about 1 to about 2.5 D less optical power than theablated profile 20. This amount of lesser curvature of the covering cancorrect temporary myopia related to epithelial irregularity 12I and mayalso smooth the irregularity based on the deflection pressure asdescribed herein, for example.

While the outer portion 120 can be fit in many ways, the outer portion120 may comprise radius of curvature R1B corresponding to about 0 to 2Dless optical power than the corresponding optical power of the unablatedcornea having curvature RC. For example, the unablated portion of thecornea may have an optical power of about 43D, and the outer portion 120may have a curvature R1B corresponding to about 41 to 43D, such that thecovering is fit on the cornea with a fit ranging from matched to loose.Such fitting can be used with tri-curved coverings as described herein.

The tri-curve and oblate covering profiles as described herein can besized similarly to the bicurve surface so as to provide inner portion110 with a decreased curvature and increased radius of curvaturerelative to ablation profile 20 so as to promote epithelialregeneration. For example inner portion 110 may comprise an increasedapical radius of curvature relative to the radius of curvature of theablation profile 20 of the cornea.

The amount of decreased curvature of inner portion 110 can becharacterized in many ways, for example with Diopters of the cornea andDiopters of the front or back surface of the inner portion of thecovering. In many embodiments the covering may comprise an inner portionhaving radius of curvature R1 that can be about 2D less than the opticalpower of the ablated cornea. For example, when the cornea is ablatedfrom about 43D to about 40D, the base radius of curvature R1 of covering100 correspond about 38D, two Diopters flatter than the ablated corneaso as to provide environment 100E.

The deflectable coverings having the amount of relative rigidity withinthe ranges as described herein can be fit to the ablated cornea in manyways. As the covering deflects, the patient can be fit with a coveringthat can be flatter or steeper than the ablation prior to placement onthe eye, and when the covering is placed on the eye the covering candeflect substantially in response to the shape of the ablation so thatthe patient can see and receive the visual benefit of the ablationprofile.

In many preferred embodiments, the amount of the difference in curvaturebetween the front surface of the ablation profile and the covering priorto placement on the eye can be within a range from about 0D to about 3Dso as to promote vision and epithelial regeneration. For example, thecovering prior to placement with configuration 100C1 can be flatter thanthe cornea by an amount within a range from about 1D to about 3D, andwhen placed on the eye the covering deflects so as to conform at leastpartially to the ablated cornea. The epithelium may comprise a thicknessof about 50 um. The covering prior to placement with configuration 100C1having a curvature flatter than the cornea can decrease pressure to theepithelium near the edge of the covering as the covering with theflatter curvature may be deflected less when the inner portion conformsto the ablation. The covering prior to placement with configuration100C1 having a curvature flatter than the cornea can increase pressureto the epithelium along the inner portion of the ablation as thecovering may be deflected less when the inner portion conforms to theablation.

In many embodiments the inner portion 110 has a substantially uniformthickness and no substantial optical power such that the optical powerof the covering corresponding to the index of refraction of thecovering, the upper surface of the covering, and the lower surface ofthe covering, comprises no more than about +/−1.5D, for example no morethan +/−1D. When the covering having the substantially uniform thicknessis placed on the eye and deflected so as to conform at least partiallyto the ablation and smooth the inner 2-3 mm of the cornea, the coveringcorresponds substantially to the ablation profile such that the patientcan see.

FIG. 1M shows deflection of a portion of a covering in response to anepithelial irregularity so as to smooth the irregularity. Theregenerating epithelium comprises a smoothed regeneration profile 12RPSand a smoothed irregularity 12S. For reference, the regeneration profile12RP without the covering and irregularity 12I without the covering areshown. The covering can smooth the epithelium with pressurecorresponding to deflection of the covering as described when thecovering 100 comprises a second configuration 100C2 as described herein.

FIG. 1N shows a test apparatus 190 to measure deflection of a portion ofa lens in response to a load. The test apparatus 190 may comprise arigid support having an aperture 192, such that deflection of thecovering 100 through the aperture 192 can be measured. The aperture 192has a dimension across 194 that can be sized smaller than the dimensionacross inner portion 110, so as to measure a deflection 110D of theinner portion 110 in response to a load 196. The deflection 110D maycomprise a peak deflection, for example a distance. The load 196 maycomprise a point load or a load distributed over an area correspondingto diameter 104, for example a pressure from a gas or liquid on thelower side of the covering. The covering may comprise a firstconfiguration 100C1 corresponding to the shape of the covering prior toplacement on the eye, and the covering may comprise a secondconfiguration 100C2 when placed on the eye, and the amounts of forceand/or pressure to deflect covering 100 can be determined such thatcovering 100 can be deflected without substantially degrading vision andso as to smooth the epithelium. For example, the covering may deflectslightly so as to decrease vision no more than about 1 or 2 lines ofvisual acuity and such that the covering can smooth the epithelium andprovide environment 100E as described herein.

The modulus and thickness of the covering can be used to determine anamount of relative rigidity of the covering 100, the correspondingamount of force to deflect the covering 100 across a distance, and thecorresponding amount of pressure to smooth the epithelium with thedeflected covering as described herein.

The amount of relative rigidity can be determined based on the modulusmultiplied with cube of the thickness. The amount of deflectioncorresponds to the 6^(th) power of the deflected span across thecovering, the modulus, and the cube of the thickness. The approximatelyfourth order relationship of the span to the deflection can allow thecoverings as described herein to conform at least partially to theablation profile within a range from about 4 to 6 mm, and inhibitsubstantially irregularities having diameters of about 3 mm or less, forexample.

The deflection can be approximated with the following equation:

Deflection≈(constant)*(Load*Span̂4)/(Modulus*thicknesŝ3)

The above approximation can be useful to understand the properties ofcovering 100, for example with a substantially uniform thickness of theinner portion. The substantially uniform thickness may comprise athickness that is uniform to within about +/−25%, for example to withinabout +/−10%, such that the covering can conform substantially to atleast a majority of the surface area of an ablation zone and inhibitirregularities over a smaller portion of the ablation zone correspondingto no more than a minority of the surface area of the ablation. In manyembodiments, the covering conforms over an area having diameter of atleast about 4 mm and inhibits irregularities over an area having adiameter of no more than about 4 mm, for example less inhibitsirregularities over an area of no more than about 3 mm. For example,based on the above equations, the deflection is related to the fourthpower of the span, such that for a comparable load, a 2 mm span willhave about 1/16^(th) the deflection of a 4 mm span. Similarly, a 3 mmspan will have a deflection that is about 1/16^(th) the deflection of a6 mm span. As the deflection is related to the cube of the thickness,doubling the thickness can decrease the deflection by about a factor of8. The above approximations can be combined with clinical testing todetermine thicknesses and moduli suitable for incorporation inaccordance with embodiments as described herein.

The equations for deflection of an unsupported circular span of amaterial having a substantially uniform thickness are:

$E_{c} = {{E_{1}\left( \frac{t_{1}}{t_{1} + t_{2}} \right)} + {E_{2}\left( \frac{t_{2}}{t_{1} + t_{2}} \right)}}$  Rigidity = E_(c)(t₁ + t₂)³$y = {\frac{3{wR}^{4}}{16{Et}^{3}}\left( {5 + v} \right)\left( {1 - v} \right)}$$w = \frac{y\; 16{Et}^{3}}{\left( {5 + v} \right)\left( {1 - v} \right)3R^{4}}$

where:W=evenly distributed load over the surface, Pressure (Pa)R=span of unsupported material (m)

E=Young's Modulus (Pa)

t=Thickness (m)v=Poisson's Ratio (unit-less, assumed to be constant among materials)y=Deflection (m)

Equations for deflection is described in Theory and Analysis of ElasticPlates, Junuthula Narasimha Reddy, p. 201 equation 5.3.43(1999).

Although the above equations describe relative rigidity for asubstantially flat surface, the equations can approximate a curvedsurface and a person of ordinary skill in the art can determine thedeflection load and relative rigidity empirically based on the teachingsdescribed herein, for example with finite element modeling.

TABLE A1 Material, modulus, thickness, relative rigidity Dk/anddeflection load of inner portions of coverings as described herein.Uniform Button Button Flexural Flexural Relative Button ThicknessThickness Modulus Modulus Rigidity Material Material (um) (m) (MPa) (Pa)(Pa*m{circumflex over ( )}3) Dk Dk/t Rigid 250 2.50.E−04 35 350000005.47E−04 600 240 Silicone Rigid 200 2.00.E−04 35 35000000 2.80E−04 600300 Silicone Rigid 150 1.50.E−04 35 35000000 1.18E−04 600 400 SiliconeRigid 100 1.00.E−04 35 35000000 3.50E−05 600 600 Silicone Rigid 505.00.E−05 35 35000000 4.38E−06 600 1200 Silicone Exemplary 293 2.93.E−0420 20000000 5.03E−04 600 205 Silicone Exemplary 272 2.72.E−04 2020000000 4.02E−04 600 221 Silicone Exemplary 250 2.50.E−04 20 200000003.13E−04 600 240 Silicone Exemplary 215 2.15.E−04 20 20000000 1.99E−04600 279 Silicone Exemplary 200 2.00.E−04 20 20000000 1.60E−04 600 300Silicone Exemplary 175 1.75.E−04 20 20000000 1.07E−04 600 343 SiliconeExemplary 150 1.50.E−04 20 20000000 6.75E−05 600 400 Silicone Exemplary100 1.00.E−04 20 20000000 2.00E−05 600 600 Silicone Exemplary 505.00.E−05 20 20000000 2.50E−06 600 1200 Material enflufocon A 252.50.E−05 1900 1900000000 2.97E−05 18 72 (Boston ES) enflufocon A 505.00.E−05 1900 1900000000 2.38E−04 18 36 enflufocon A 150 1.50.E−04 19001900000000 6.41E−03 18 12 hexafocon B 25 2.50.E−05 1160 11600000001.81E−05 141 564 (Boston XO2) hexafocon B 50 5.00.E−05 1160 11600000001.45E−04 141 282 hexafocon B 150 1.50.E−04 1160 1160000000 3.92E−03 14194

As shown in Table A1, an RGP material such as an enflufocon or hexafoconhaving a thickness of about 50 um can have a relative rigidity suitablefor epithelial smoothing and so as to conform at least partially to theablated stroma. The rigid silicone having a modulus of about 20 MPa anda thickness of about 250 um will provide a relative rigidity 3E-4 anddeflection under load similar to the RGP material having a thickness ofabout 50 um and modulus of about 1900 MPa so as to provide a relativerigidity of about 2.4E-4. Commercially available RGP lens materials asshown in Table A1 can be combined in accordance with embodiments asdescribed herein so as to provide covering 100. Based on the teachingsdescribed herein, a person of ordinary skill in the art can determinethe thickness of the covering based on the modulus and the intendedrelative rigidity.

Work in relation to embodiments in accordance with clinical studies asdescribed herein has shown that the inner portion 110 of the covering100 having the relative rigidity of about 3E-4 (3×10⁻⁴ Pa*m̂3) can beeffective so to improve vision and conform at least partially of the eyeso as to provide at least some comfort and improve fitting. Many eyeshave been measured with many coverings and work in relation toembodiments indicates that an inner portion 110 having a relativerigidity within a range from about 1E-4 to about 5E-4 (Pa*m̂3) can allowthe covering to conform to the ablation and smooth the epithelium asdescribed herein. For example, inner portion 110 may have a relativerigidity within a range from about 2E-4 to about 4E-4, and the eye canbe fit accordingly based on the deflection of the covering 100.

The relative rigidity can be related to the amount of deflection of thecovering 100 on the eye. Work in relation to embodiments indicates thata relative rigidity of inner portion 110 about 3E-4 can deflect about+/−2D when placed on the eye so as to conform to an ablation to withinabout +/−2D across the approximately 5 or 6 mm ablation diameter when aninner diameter of about 2 or 3 mm is smoothed. A covering 100 having arelative rigidity of about 1.5 E-4 can deflect about +/−4D when placedon the eye so as to conform to an ablation to within about +/−4D acrossan approximately 5 or 6 mm diameter when an inner diameter of about 2 or3 mm is smoothed.

The outer portion of the covering may comprise a relatively rigidityless than the inner portion to fit an outer portion of the eye such asan outer portion of the cornea or to fit the sclera when placed on theconjunctiva.

The coverings as described herein may comprise a relative rigiditycorresponding to a range within two or more values of many of thecoverings of Table A1, for example a relative rigidity within a rangefrom about 2.50E-06 to about 6.41E-03(Pa*m̂3), and two or moreintermediate values for example within a range from about 6.75E-05 toabout 5.47E-04(Pa*m̂3). Based on the teachings described herein thecovering can have a relative rigidity within one or more of many rangessuch as within a range from about 0.5 E-3 to about 10 E-3 (Pa*m̂3), forexample a range from about 1 E-3 to about 6 E-3, for example. Based onthe teachings described herein, a person of ordinary skill in the artcan conduct clinical studies to determine empirically the thickness andmodulus corresponding to a relative rigidity of the inner portion 110for the covering 100 so as to smooth irregularities and conformsubstantially to the ablation zone.

TABLE A2 Pressure for 5 um deflection at diameters of 3, 4, 5 and 6 mmfor coverings of Table A1. Pressure Required to obtain 5 um ButtonRelative deflection (Pa) Button Thickness Rigidity 3 mm 4 mm 5 mm 6 mmMaterial (um) (Pa*m{circumflex over ( )}3) span span span span Rigid 2505.47E−04 1002.2 317.1 129.9 62.6 Silicone Rigid 200 2.80E−04 513.1 162.466.5 32.1 Silicone Rigid 150 1.18E−04 216.5 68.5 28.1 13.5 SiliconeRigid 100 3.50E−05 64.1 20.3 8.3 4.0 Silicone Rigid 50 4.38E−06 8.0 2.51.0 0.5 Silicone Exemplary 293 5.03E−04 921.9 291.7 119.5 57.6 SiliconeExemplary 272 4.02E−04 737.6 233.4 95.6 46.1 Silicone Exemplary 2503.13E−04 572.7 181.2 74.2 35.8 Silicone Exemplary 215 1.99E−04 364.3115.3 47.2 22.8 Silicone Exemplary 200 1.60E−04 293.2 92.8 38.0 18.3Silicone Exemplary 175 1.07E−04 196.4 62.2 25.5 12.3 Silicone Exemplary150 6.75E−05 123.7 39.1 16.0 7.7 Silicone Exemplary 100 2.00E−05 36.711.6 4.8 2.3 Silicone Exemplary 50 2.50E−06 4.6 1.4 0.6 0.3 Siliconeenflufocon A 25 2.97E−05 54.4 17.2 7.1 3.4 (Boston ES) enflufocon A 502.38E−04 435.2 137.7 56.4 27.2 enflufocon A 150 6.41E−03 11751.3 3718.21523.0 734.5 hexafocon B 25 1.81E−05 33.2 10.5 4.3 2.1 (Boston XO2)hexafocon B 50 1.45E−04 265.7 84.1 34.4 16.6 hexafocon B 150 3.92E−037174.5 2270.1 929.8 448.4

The data of Table A1 and A2 show that the pressure to deflect a 3 mmzone a distance of 5 um can be about three times the pressure to deflecta 4 mm zone the distance of 5 um, and about 15 times the pressure todeflect the 6 mm zone the 5 um distance. For example, for the relativerigidity of about 3.13E-4 (Pa*m̂3), the 5 um deflection pressures are572.7, 181.2, 74.2, 35.8 (Pa) for diameters of 3, 4, 5 and 6 mm,respectively, such that the central 3 mm of inner portion 110 canprovide a compressive force to irregularities of about 570 Pa when theinner portion 110 conforms to the ablation across a 6 mm span with apressure of about 35 Pa, for example.

The relative rigidity and deflection pressures can be determined formany coverings based on the teachings described herein, for example forcoverings having a plurality of layers having a plurality of materials.

TABLE A3 Relative Rigidity of Layered Coverings Material 2 (Soft)Composite Material 1 (Rigid) Flexural Composite Relative Total LayeredThickness Modulus Thickness Modulus Thickness Modulus Rigidity ThicknessMaterial (m) (Pa) (m) (Pa) (m) (Pa) (Pa*m{circumflex over ( )}3) 270Exemplary 2.40E−04 2.00E+07 3.00E−05 2.00E+06 2.70E−04 1.80E+07 3.54E−04um Silicone thick Shield Soft and 1.35E−04 2.00E+07 1.25E−04 2.00E+062.70E−04 1.13E+07 1.99E−04 Hard are Equal 150 Exemplary 1.20E−042.00E+07 3.00E−05 2.00E+06 1.50E−04 1.64E+07 5.54E−05 um Silicone thickShield Soft and 7.50E−05 2.00E+07 7.50E−05 2.00E+06 1.50E−04 1.10E+073.71E−05 Hard w/ Equal thickness

When two or more materials are combined so as to provide two or morelayers, the relative rigidity of each layer can be combined so as todetermine a total composite rigidity. For example, the combined rigiditycan be determined for a covering having first layer 100L1 of firstmaterial, a second layer 100L2 of second material 110M2 and third layer100L3 of third material 100L3, in which the first and third materialscan be the same material.

A weighted average system can be used to treat the two layers as onematerial. The relative amounts of each material and the moduli of thetwo materials can be combined to determine a composite modulus based onthe weight average of the thickness of each layer. For example, with 90um of 20 Mpa material layer and a 10 um of 5 MPa material layer can becombined so as to determine the composite modulus as 20 MPa*0.9+5MPa*0.1=18.5 MPa

The equations described herein accommodate many layers of differentmaterials and thicknesses.

Based on the composite modulus, one can multiply the composite modulusby the overall thickness cubed, in the present example 18.5 MPa*100̂3.Although these calculations can be based on approximations, a person ofordinary skill in the art can conduct simulations, for example finiteelement modeling simulations, so as to determine the amount of relativerigidity, pressures and deflection forces and pressures as describedherein.

The index of refraction of one or more layers of covering 100 maycorrespond substantially to the index of refraction of the cornea.

One or more of the materials 110M1, 110M2 or 110M3 may comprise an indexof refraction within a range from about 1.38 to about 1.43 so as tomatch the index of refraction of the cornea to within about +/−0.05. Forexample, the materials 110M1 and 110M3 may comprise an opticallytransparent soft silicone elastomer having an index of refraction ofabout 1.41 and the material 110M2 may comprise an optically transparentrigid silicone elastomer having an index of refraction of about 1.43,for example available from NuSil. Alternatively, material 110M1 andmaterial 110M3 may comprise silicone hydrogel and material 110M2 maycomprise silicone, for example.

While the covering may comprise similar materials such as a more rigidsilicone combined with a softer silicone, the covering may comprisedissimilar materials. For example, and RGP material can be combined witha hydrogel, such as the bicurve or tricurve embodiments as describedherein. The covering can extend at least to the limbus for stability.The RGP material may comprise the second layer 100l 2 of the secondmaterial 110M2, for example in accordance with Table A, and the hydrogelmay comprise the first layer 100l 1 of the first material 110M1 and thethird layer 100l3 of the third material 110M3. The hydrogel may have anindex of refraction from about 1.38 to about 1.42 so as to match theindex of refraction of the cornea of about 1.377 to within about 0.05and may comprise one or more of HEMA, NVP, GMA, MMA, SiH, TRS, HEMA/NVP,MMA/NVP, HEMA/GMA, or SiH/TRS, commercially available from Vista Optics,UK, for example. The hydrogel comprising HEMA/NVP, MMA/NVP, or HEMA/GMAmay have water content within a range from about 40% to about 70% so asto comprise the index of refraction within the range from about 1.38 toabout 1.43. A water content of about 40% corresponds to an index ofrefraction of about 1.43 and a water content of about 70% corresponds toan index of refraction of about 1.38. The hydrogel comprising SiH/TRSmay comprise water content within a range from about 20% to about 70% soas to comprise the index of refraction within the range from about 1.38to about 1.43. With these SiH hydrogels a water content of about 20%corresponds to an index of refraction of about 1.43 and a water contentof about 70% corresponds to an index of refraction of about 1.38.

Coverings Configured to Pump Tear Liquid

FIG. 2A1 shows covering 100 configured to pump tear liquid whenpositioned on a blinking eye.

FIG. 2A2 shows the covering of FIG. 2A1 configured to pump tear liquidunder the covering. The covering 100 has inner portion 110 and outerportion 120, and fenestrations 100F extending through the thickness ofthe covering on the outer portion so as to tear liquid TL, which maycomprise a medicament. The medicament may comprise an anesthetic, ananalgesic, or other medication, for example.

The covering 100 comprises an optical component 100A and a couplingcomponent 100B. The optical component 100A may comprise an inner portion110 of covering 100 and the coupling component 100B may comprise anouter portion 120 of covering 100. The optical component 100A comprisesrigidity sufficient to resist deformation such that the opticalcomponent 100A can correction vision of the eye. The optical component100A may comprise a single layer of material, or a plurality of layersof materials. The coupling component 100B may comprise a rigidity lessthan optical component 100A, such that the coupling component can one ormore of deflect or elastically deform so as to conform to the corneawhen covered with the eyelid. The coupling component 100B may comprisean inner component 100B1 to couple to the optical component, an outerportion 100B3 to couple to the sclera, and an intermediate portion100B2. The intermediate portion 100B2 can extend between the innercomponent 100B1 and the outer component 100B3 so as define a chamberwhen placed on the eye.

The optical component 100A and the coupling component 100B can pump tearliquid under the cornea when the eye closes and opens, for example whenthe eye blinks. The outer component 100B3 comprising outer portion 120may comprise fenestrations 100F. For example, the intermediate portion100B2 may comprise fenestrations 100F. The outer portion 120 maycomprise outer portion 100B3 comprising a sclera coupling portion 130 tocontact the conjunctiva over the sclera and peripheral portion 120P. Thesclera coupling portion 130 may comprise a thin flange portion extendingto the peripheral portion 120P. The sclera coupling portion may comprisea thin elastic portion capable of elastic deformation when the eyeblinks to allow the optical component to move downward. Alternatively orin combination, the outer portion 120 may comprise a rigidity sufficientto deflect when the eye blinks.

FIG. 2A3 shows a schematic illustration of the covering of FIGS. 2A1 and2A2 pumping tear liquid when the eye closes, in accordance withembodiments of the present invention;

When placed on the eye, the covering 100 can define a chamber with thelower surface of the covering extending along the cornea, the limbus andconjunctiva over the sclera. When the eyelids are separated, thecovering 100 is held loosely on the eye with slight pressure from theeyelids extending under the outer portion of the covering. When the eyeblinks, the lids extend over the outer portion 120 of the covering andinner portion 110 so as to exert pressure on the covering such that thecovering is urged downward toward the cornea and the volume of thechamber under the covering is decreased. The downward movement of theoptical component 100A of the inner portion 110 of the covering 100 canmove the covering downward so as to pass pumped tear liquid 100TLthrough the fenestrations, and in many embodiments the pumped tearliquid 100TL can pass under the peripheral portion 120P.

FIG. 2A4 shows a schematic illustration of the covering of FIGS. 2A1 and1A2 pumping tear liquid when the eye opens, in accordance withembodiments of the present invention.

When the eyelids open, the pressure on the covering is decreased, suchthat the covering can move away from the cornea and increase the volumeof the chamber. The movement of the optical portion 100A away from thecornea can draw pumped tear liquid 100TL into the covering through thefenestrations, and contact of the peripheral portion 120P and scleracoupling portion 130 with the conjunctiva can inhibit flow of tearliquid under the peripheral portion 120P. In many embodiments, theperipheral portion 120P and sclera coupling portion 130 can contact theconjunctiva so as to form a seal when the eyelids open and the opticalportion 100A moves away from the cornea.

The fenestrations 100F can be located away from the optical component,for example about 3.5 to about 4.5 mm from a center of the opticalcomponent to decrease optical artifacts of the fenestrations 100F.However, the fenestrations may be located within the optical componentwhen one or more of sufficiently small or sufficiently few so as to notproduce perceptible visual artifacts. The fenestrations may comprise apatter to indicate the orientation of the covering 100 on the cornea.For example the upper fenestration and lower fenestrations may indicateda 90 degree axis on the patient and horizontal fenestrations can beprovided to indicated the location of the 180 degree axis on thepatient. The fenestrations may comprise additional fenestrations to belocated inferiorly to indicate that the covering is not flipped by 180degrees on the patient, for example upside down. The additional inferiorfenestrations may also couple to the rivulet comprising tear liquid thatforms near the lower lid, so as to facilitate pumping of tear liquid.For example, when the eye blinks the lower lid may extend over theinferior fenestrations and the upper lid may extend downward to coupleto the lower rivulet. When the eye opens and the eyelids separate theupper eyelid can draw tear liquid of the rivulet over the upperfenestration and the lower eyelid can move inferiorly so as to pass therivulet over the inferior rivulets.

The covering 100 may comprise a base radius R1 of curvaturecorresponding to a curvature of a central portion of the cornea. Thecovering 100 comprises a first configuration 100C1 when placed on thecornea and the eyelids are spaced apart and a second configuration 100C2when placed on the cornea and the blinks such that the eyelids. Thefirst configuration 100C1 and the second configuration 100C2 pump tearliquid under the covering 100.

The covering 100 may comprise a lower surface corresponding to one ormore of many suitable shapes to fit the covering to the cornea, such asa natural unablated cornea or an ablated cornea following refractivesurgery such as PRK. The lower surface of the inner portion 110 of thecovering 100 may correspond to base radius of curvature. With postablation corneas, the covering can resist deformation and smooth theepithelium over about 3 mm and may deflect so as to conformsubstantially to the ablated cornea over a larger dimension such as 6mm. The covering may comprise a second curve in combination with a firstcurve, such that the lower surface comprises a bicurve surface.Alternatively, the lower surface may correspond to an aspheric surface.For example, an aspheric surface may comprise an oblate shape and conicconstant to fit a post PRK eye. The curved and aspheric surfaces asdescribed herein can fit non-ablated eyes and the covering can beselected by based on the curvature of an unablated central region of thecornea. Also, it may be helpful to identify a covering that fits thecornea, for example with selection of one covering from a plurality ofsizes.

The covering 100 may comprise an inner portion 110 having an opticalcomponent 1 100A. The optical component 100A may comprise an innerportion 110 of the covering 100. The optical component may have amodulus within a range from about 5 MPa to about 40 MPa, and a thicknesswithin a range from about 100 um to about 300 um such that centralportion can have sufficient rigidity to resist deformation and smoothirregularities and correct vision. The covering may comprise anelastomeric stretchable material such that the covering can stretch tofit the cornea, for example. The covering having the modulus within arange from about 4 MPa to about 40 MPa can be formed in many ways asdescribed herein. For example, the covering may comprise a single pieceof material having a non-uniform thickness extending across the cornea.The covering can be shaped in many ways and may comprise a single pieceof one material, or may comprise a single piece composed to two similarmaterials, or may comprise a plurality of materials joined together.

FIG. 2B1 shows covering 100 having a tricurve profile to fit sclera andcornea. The tricurve profile can be used to fit an unablated naturaleye, in which the base curvature R1 corresponds to the optically usedcentral portion of the cornea. For ablated corneas, the base curvatureR1 may correspond to the ablated cornea. The tricurve covering maycomprise an inner portion with an inner lower surface having radius ofcurvature R1 and an outer portion comprising an outer lower surfacehaving radius of curvature R1B. The outer portion 120 may comprise thesclera coupling portion 130 having a third radius of curvature R1C sizedto fit the conjunctiva located over the sclera and contact theconjunctiva so as to inhibit sliding movement of inner portion 110. Workin relation to embodiments suggests that coupling to the sclera mayimprove alignment of the lens on the cornea.

The covering 100 having the tricurve profile may comprise dimensionssized to fit the cornea and sclera of the eye 2. The covering 100 havingthe at least tricurve profile may comprise an inner portion 110 and anouter portion 120 as described herein. The outer portion 120 maycomprise the third sclera coupling portion 130 having curvature R1Cshaped to fit the sclera of the eye, for example shaped so as to contactthe conjunctiva of the eye such that the conjunctiva is located betweenthe sclera and the sclera coupling portion 130. The inner portion 110may comprise a dimension 102 and the outer portion 120 may comprise adimension 104 as described herein. The covering 100 may comprise a sagheight 105 extending between an upper location of the inner portion 110and the outer boundary of outer portion 120 shaped to fit the cornea.The sclera coupling portion 130 may comprise a dimension across 103.

The dimension 102, the dimension 104, the dimension 103, the dimension105 and the dimension 105S can be sized to the eye based on measurementsof the eye. The dimension 103 may correspond to an annular region of thesclera extending from the limbus to the outer boundary of the scleracoupling portion across a distance within a range from about 1 to 4 mm,for example within a range from about 1.5 to 2 mm. The size of thelimbus of the eye can be measured so as to correspond to dimension 104,for example, and can be within a range from about 11 to 13 mm. Thedimension 105 may correspond to a height of the eye from the vertex ofthe cornea to the limbus, and the dimension 105S may correspond to thesag height were the outer location of the covering couples to theconjunctiva covering the sclera.

The dimension 102 may correspond to an inner region of the naturalcornea or the dimension across an ablation. Dimension 102 may correspondto the more rigid inner portion 110 can be sized about 0.5 to about 2 mmless than the dimension across the ablation zone, such that the soft andless rigid outer portion 120 contacts the eye near the edge of theablation and the epithelial debridement.

The radius of curvature R1C of portion 130 can be determined so as tofit the eye, and can be within a range from about 12 mm+/−3 mm. Theradius R1B of the outer portion can be fit to within about +/−0.5 mm,for example to within about +/−0.25 mm.

The dimensions of the covering 100 can be determined in many ways, forexample with topography measurements of the cornea and sclera. Thecorneal and scleral topography can be measured with many instruments,such as with the Orbscan™ topography system commercially available fromBausch and Lomb, and the Pentacam™ Scheimpflug camera systemcommercially available from Oculus, and commercially available opticalcoherence tomography (OCT). The ablation profile can be combined withthe topography to determine the shape of the eye.

The dimensions of covering 100 can be sized to one or more of the corneaand sclera based on tolerances that may be determined clinically.

The outer portion 120 and sclera coupling portion 130 may comprise ahydrogel material, for example a silicone hydrogel material, and theinner portion 110 may comprise the rigid material 110M, for examplesecond layer 100L2 and second material 110M2 between first layer 100L1of first material 110M1 and third layer 100L3 of third material 110M3 asdescribed herein.

The portions of the coverings as described herein, for example the innerportion and the outer portion, may comprise a junction wherein a firstportion connects with a second portion, and the junction may have themodulus as described herein. The covering may comprise a contact lenshaving a central lens portion having a center stiffness of at leastabout 2 psi*mm2 coupled to an outer lenticular junction portion having alenticular junction stiffness of at least about 5 psi*mm2.

FIG. 2B2 shows covering 100 having a tricurve profile to fit sclera withslopes of the curved profiles aligned so as to inhibit ridges at theboundaries of the curved portions, in accordance with embodiments of thepresent invention. The inner portion 110 comprises the optical component100A and the outer portion 120 comprises the coupling component 100B.The coupling component 100B may comprise a thin layer of material 120Mextending under the optical component 100A for improved comfort andsupport of the optical component. The outer portion 120 comprisingcoupling component 100B may comprise fenestrations 100F as describedherein. The inner portion 120 comprises first radius R1 along the lowersurface and a first anterior radius R1A along the upper surface. Theouter portion 120 couples to the inner portion with a second radius R1Baligned with the first radius R1A at a boundary corresponding todimension 102. The outer portion 120 has a second anterior radius R1BAextending along the anterior surface. The outer portion 120 comprisingsecond radius R1B along the lower surface to contact the cornea maycouple to sclera coupling portion 130 at a location corresponding to thelimbus of the eye, for example along a boundary corresponding todimension 104. Work in relation to embodiments suggests that formationof a ridge near the boundary of the cornea contacting portion and scleracoupling portion may decrease epithelial cell migration somewhat morethan would be ideal, and the alignment of the curved profiles to inhibitridge formation can provide a smooth transition over the limbus and maydecrease mechanical pressure to the limbus. The sclera contactingportion 130 comprises an upper surface having an anterior radius ofcurvature RICA.

The inner portion 110 can be curved to fit an ablated eye or anon-ablated eye. The modulus and thickness of the sclera couplingportion can be configured in many ways to fit many eyes with comfort andso as to resist movement of the inner portion 120. The modulus of scleracoupling portion 130 may be no more than about 5 MPa and the thicknessno more than about 200 um, for example no more than 100 um, so as tostretch substantially for comfort and resist movement of the innerportion when placed on the sclera.

The dimension 103 of sclera coupling portion 130 may correspond to anannular region of the sclera extending from the limbus to the outerboundary of the sclera coupling portion across a distance within a rangefrom about 1 to 4 mm, such that the dimension 103 can be from about 12mm to about 16 mm, for example from about 14 mm to about 16 mm.

The radius of curvature R1C, thickness and modulus of the portion 130can be configured so as to fit the eye to resist movement of innerportion 110 and with comfort. The radius of curvature R1C can be sizedless than the radius of curvature of the sclera and conjunctiva. Forexample, the radius of curvature R1C can be no more than about 10 mm,for example no more than about 9 mm when the curvature of the scleraportion of the eye is at least about 12 mm for example. The thirdrelative rigidity may comprise no more than about 4E-5 Pa*m̂3 so as tostretch substantially for comfort and resist movement of the innerportion when the outer portion is placed on the sclera.

The thickness of the sclera coupling portion having radius of curvatureR1C can vary, for example from a thickness of about 100 um to a taperededge.

FIG. 2B2-1 shows alignment of the slope of the lower surface of thecorneal contacting portion comprising second radius R1B with the slopeof the lower surface of the sclera coupling portion 130 comprisingradius R1C, such that pressure to the limbus is decreased substantially.The second slope corresponding to second radius R1B is given by a heightR1BY and a length R1BX, and the third slope corresponding to thirdradius R1C is given by height R1CY and width R1CX. The second slope isaligned with the third slope such that no substantial ridge is formed atthe location corresponding to the limbus. For example, the first slopecan be substantially equal to the second slope. The slope of the innerportion 110 can be aligned with the slope of the second portion 120 at alocation corresponding to dimension 102 in a similar manner.

FIG. 2B3 shows a tapered edge of the covering of FIG. 2B1 having atricurve profile to fit sclera and cornea. The sclera coupling portion130 may comprise a flange 120F having a narrowing taper extending adistance 120FW to a chamfer 120FE. The chamfer 120FE can be definedalong an outer rim where a first convexly curved lower surface joins asecond convexly curved upper surface. The convex surfaces along theouter rim allow the covering to slide along the conjunctiva and thenarrowing taper permits the sclera coupling portion of the covering tostretch substantially and couple to the sclera and conjunctiva withdecreased resistance for comfort.

The dimensions of the covering 100 can be determined in many ways, forexample with one or more topography measurements or tomographymeasurements of the cornea and sclera. The corneal and sclera topographycan be measured with many instruments, such as with the Orbscan™topography system commercially available from Bausch and Lomb, and thePentacam™ Scheimpflug camera system commercially available from Oculus.The tomography can be measured with optical coherence tomography(hereinafter “OCT”) so as to determine the sag height of the limbus andconjunctiva, for example with OCT measurement systems commerciallyavailable from Zeiss/Humphrey. The ablation profile can be combined withthe topography to determine the shape of the eye.

FIG. 2B4 shows a plan view covering 100 having a multi-curve profile tofit the cornea, limbus and sclera with slopes of the curved profilesaligned so as to inhibit ridges at the boundaries of the curvedportions, in accordance with embodiments of the present invention. Thecovering 100 comprises fenestrations 100F and optical component 100A forvision correction and outer coupling component 100B that may pump tearliquid as described herein.

FIG. 2B5 shows a side sectional view of the covering of FIG. 2B4 andcorresponding curved portions to couple to the cornea, limbus andsclera, in accordance with embodiments of the present invention;

The inner portion 110 comprises optical component 100A which maycomprise material 110M. The outer portion 120 comprises couplingcomponent 100B which may comprise outer material 120M. The inner portion110 is coupled to the outer portion along a boundary corresponding todimension 102. The lower surface of inner portion 110 has a shapeprofile corresponding to a first radius R1. The outer portion 120couples to the inner portion with a first outer radius R1B1 ofcurvature, such that the slopes are aligned as described herein at alocation corresponding to dimension 102. The outer portion 120 comprisesa second outer radius R1B2 of curvature coupled to the first outerradius of curvature R1B1. The first outer radius R1B1 of curvature iscoupled to the second outer radius R1B2 of curvature with the slopesaligned as described herein at a location corresponding to dimension104A. The outer portion 120 comprises a third outer radius R1B3 ofcurvature coupled to the second outer radius of curvature R1B2. Thesecond outer radius R1B2 of curvature is coupled to the third outerradius R1B3 of curvature with the slopes aligned as described herein ata location corresponding to dimension 104B.

The first outer radius of curvature R1B1, the second outer radius ofcurvature R1B2, and the third outer radius of curvature R1B3 maycomprise values determined from a patient population. The first radiusof curvature R1 may comprise a value determined based on the patientpopulation. Alternatively or in combination, the first radius ofcurvature R1 may correspond to a post ablation profile.

The first outer radius of curvature R1B1, the second outer radius ofcurvature R1B2, and the third outer radius of curvature R1B3 can becombined or replaced with an aspheric surface such as a conic surface.The conic surface can be determined in accordance with first outerradius of curvature R1B1, the second outer radius of curvature R1B2, andthe third outer radius of curvature R1B3, such that the conic surfacecorresponds to values determined from a patient population.

The sclera coupling portion 130 may have a lower surface comprising afirst sclera coupling radius R1C1 of curvature and a second scleracoupling portion having a second sclera coupling radius R1C2 ofcurvature. The first sclera coupling portion comprising radius R1C1 canbe aligned to the third radius R1B3 at a location corresponding todimension 104. The second sclera coupling portion comprising radius R1C2can be aligned to the first sclera coupling portion having radius R1C1at a location corresponding to dimension 120FW corresponding to an innerboundary of tapering flange 120F.

FIG. 2B6 shows a side sectional view of the covering of FIG. 2B4 andcorresponding curved portions of the upper surface, in accordance withembodiments of the present invention. The upper surface may comprise aninner anterior radius of curvature R1A, a first outer anterior radius ofcurvature R1B1A, a second outer anterior radius of curvature R1B2A. Thesclera coupling portion 130 may comprise a first anterior radius R1C1Aof curvature and a second anterior coupling radius R1C2A of curvature.

FIG. 2B7 shows a tapered edge of the covering of FIG. 2B4, in accordancewith embodiments of the present invention;

FIG. 3A shows a covering 100 comprising a contact lens placed on the eyewith the eyelids separated, in accordance with embodiments of thepresent invention. The covering 100 is placed on the eye such that thetear liquid TL extends under at least a portion of the covering betweenthe covering and the cornea so as to provide a chamber 100C. Thecovering 100 can be fit so as to match substantially the curvature ofthe cornea (hereinafter “on K”) or fit slightly flatter than the corneaso as to provide chamber 100C. Alternatively or in combination, theflange 120F and sclera coupling portion 120S of the outer portion 120may comprise an angle steeper than the conjunctiva such the covering isurged away from the cornea near inner portion 110 so as to providechamber 100C. The covering 100 comprises a sag height 105S1corresponding to the elevation distance from the center of the coveringto the outer perimeter 120P of the sclera coupling portion 130. The eyelids can be separated for the patient to see an object.

FIG. 3B shows a side sectional view of the covering of FIG. 3A with theeyelids closing.

FIG. 3C shows a front view the covering of FIG. 3A with the eyelidsclosing, in accordance with embodiments. The eyelids can close with adownward movement 22A of the upper eyelid and an upward movement 22B ofthe lower eyelid. The closing of the eyelids exerts pressure on thecovering 100 such that covering 100 comprises second configuration100C2. The second configuration 100C2 comprises the sag height 105decreased to second sag height 105 S2 such that the volume of chamber100C decreases and urges pumped tear fluid 100TL from under thecovering. The pumped tear liquid 100TL flows radially outward under theouter portion 120P and through fenestrations 100F such as fenestrationsnot covered by the eyelid. The pressure of the eyelid can urge thecovering 100 toward cornea 10 so as to decrease the volume of chamber100C. The volume of chamber 100C can decrease substantially when theouter portion 120 comprising flange 120F deflects with elasticdeformation. Alternatively or in combination, the outer portion 120corresponding to the cornea can deflect so as to decrease the volume ofchamber 100C. In many embodiments, the inner portion 110 comprisingoptical component 100A may deflect with pressure of the eyelid so as todecrease the volume of chamber 100C.

FIG. 3D shows side profile the covering of FIG. 3A with the eyelidsopening, in accordance with embodiments of the present invention. Whenthe eyelids retract with upward movement 22C of the upper eyelid anddownward movement 22D of the lower eyelid, the covering 100 can returnto the first configuration 100C1 having first sag height 105S1, suchthat the volume of the chamber increases. The outer portion 120comprising flange 120F and peripheral portion 120P of the scleracoupling portion 130 may contact the conjunctiva so as to form a contactseal with the conjunctiva. The contact seal with the conjunctivaencourages flow of the tear liquid TL through the fenestrations 100F andinto the chamber 100C, such that pumped tear liquid 100TL can be locatedbetween the cornea and the covering 100.

The tear rivulet of the lower lid can move upward when the eyes close soas to provide tear liquid on the surface of the eye, and at least aportion of the rivulet can couple to the upper lid when the lids contacteach other. When the upper lid moves upward with movement 22C and thelower lid moves downward with movement 22D, the upper lid provides tearliquid TL near the upper fenestrations to pass through the upperfenestrations and the lower lid can provide tear liquid TL near thelower fenestrations to move through the lower fenestrations.

Repeated blinking of the eye may occur naturally, so as to pump tearliquid under the covering and rinse the cornea and conjunctiva under thecovering. This pumping and rinsing provided by the covering can extendthe amount of time the covering can be worn by a patient such as apatient having a normal unablated eye, and may encourage epithelialregenerations in post PRK eyes, for example.

FIG. 3E shows a covering comprising a contact lens placed on the eyesuch that the covering is supported with an inner portion of the corneaand the conjunctiva with the covering separated from an outer portion ofthe cornea so as to define a chamber when the eyelids are separated, inaccordance with embodiments of the present invention. The covering 100may contact the cornea at an inner portion of the cornea, for example ata central location. The inner portion 110 can be sized to fit the corneacentrally as described herein, for example with on K fitting. The outerportion of the covering 120 comprising flange 120F and sclera couplingportion 130 can be sized to contact the conjunctiva when the innerportion 110 contacts the sclera centrally, such that chamber 100C isformed over the outer portion of the cornea with a gap extending betweenthe outer portion of the cornea and the covering. The outer portion 120of the covering extending over the outer portion of the cornea may havea curvature less than the cornea, such that the outer portion 120 overthe outer portion of the cornea can form chamber 100C when the innerportion 110 is supported with the cornea and the outer portion 120comprising flange 120F is coupled to the conjunctiva. The fenestrations100F can be located on the covering to correspond with a location ofchamber 100C and the gap when the eyelids are open. The outer portion120 comprises a resistance to deflection sufficient to form chamber 100Cwhen the eyelids are open and insufficient to resist deflection when theeyelids close and move over the outer portion such that the outerportion moves toward the cornea and decrease the gap distance when theeyelids at least partially cover the outer portion 120.

The covering 100 can be fit to the cornea to encourage formation of thechamber 100C and such that covering 100 comprises an initialconfiguration 100C1 with chamber 100C formed beneath. The cornea maycomprise a limbus sag height 105L corresponding to an elevationaldistance extending from a vertex of the cornea to the limbus. The limbusmay be located a radial distance 105RL from a measurement axis of theeye. The eye may comprise a conjunctiva sag height 105C at a radialdistance 105RC from the axis of the eye. The covering may comprise alimbus sag height 105LC at a location corresponding to the radialdistance 105RL to the limbus. The covering may comprise a conjunctivasag height 105CC at a conjunctiva contacting location corresponding tothe radial distance 105RC of the conjunctiva, for example along flange120F. In many embodiments, the sag height 105LC of the covering at thelocation corresponding to the limbus is no more than the limbus sagheight 105L, and the sag height 105CC of the covering at the locationcorresponding to the conjunctiva is no more than the conjunctiva sagheight 105C, such that pressure to the limbus is decreased. When thecovering is placed on the eye, the conjunctiva coupling portion 130comprising flange portion 120F can deflect such that the sag height ofthe conjunctiva contacting portion is decreased from 105CC the sagheight of the conjunctiva to the sag height of the conjunctiva 105C,such that the sag height of the covering comprises a sag deflected sagheight 105S2.

FIG. 3F shows a side sectional view of the covering of FIG. 2E with theeyelids closing such that covering 100 comprises a configuration 100C2with chamber 100C having a decreased volume. When the eyelids close, theupper and lower lids exert pressure on the covering such that thecovering is urged toward the outer portion of cornea and theconjunctiva. The outer portion of the covering over the outer portion ofthe cornea may not have sufficient resistance to deflection such thatthe outer portion of the covering is deflected downward toward the outerportion of the cornea. The gap distance extending between the outerportion of the covering over the outer portion of the cornea isdecreased, such that the volume of chamber 100C decreases and pumpedtear liquid 100TL flow from chamber 100C through fenestrations 100F andunder the conjunctiva contacting portion 130 comprising flange portion120F. The upper eyelid can extend across the pupil so as to coverinferior and superior fenestrations 100F. The upper eyelid may contactthe lower eyelid so as to draw the tear liquid of the rivulet superiorlywhen the eye opens, such that tear liquid of the rivulet can be drawninto the chamber through the inferior and superior fenestrations.

The deflection of the outer portion of the covering over the outerportion of the cornea can be provided with a covering having a relativerigidity within a range from about 1.0 E-6 Pa*m̂3 to about 6 E-4 Pa*m̂3,for example from about 2.5 E-6 Pa*m̂3 to about 5 E-4 Pa*m̂3. Table A2shows values suitable of relative rigidity and corresponding ranges ofouter portion 120 corresponding to the outer portion of the cornea thatcan be determined based on the teachings described herein so as todetermine the relative rigidity of the outer portion of the covering toprovide resistance to deflection and form the chamber with the gap whenthe eyelid is away from the portion of the covering and so as to deflecttoward the cornea and decrease the gap and corresponding chamber volumewhen the eyelid covers the portion of the covering.

The deflection of the sclera contacting portion 130 to couple to theconjunctiva can be provided with the sclera contacting portion 130comprising a relative rigidity of no more than about 2 E-4 Pa*m̂3, forexample no more than about 1 E-4 Pa*m̂3, and in many embodiments no morethan about 2 E-5 Pa*m̂3. Table A2 shows values suitable of relativerigidity and corresponding ranges of sclera coupling portion 130 thatcan be determined based on the teachings described herein so as todetermine the relative rigidity of the sclera coupling portion of thecovering to provide resistance to deflection and form the chamber withthe gap when the eyelid is away from the portion of the covering and soas to deflect toward the cornea and decrease the gap and correspondingchamber volume when the eyelid covers the outer portion of the coveringover the outer portion of the cornea.

The deflection of the flange portion 120F to couple to the conjunctivacan be provided with the flange portion 130 comprising a relativerigidity of no more than about 1 E-4 Pa*m̂3, for example no more thanabout 2 E-5 Pa*m̂3, and in many embodiments no more than about 2.5 E-6Pa*m̂3. Table A2 shows values suitable of relative rigidity andcorresponding ranges of outer flange portion 120F that can be determinedbased on the teachings described herein so as to determine the relativerigidity of the flange portion 120F of the covering to provideresistance to deflection and form the chamber with the gap when theeyelid is away from the portion of the covering and so as to deflecttoward the cornea and decrease the gap and corresponding chamber volumewhen the eyelid covers the outer portion of the covering over the outerportion of the cornea.

FIG. 3F1 shows a side sectional view of the covering of FIG. 3F withrotation of the eye when the lids close such that sliding of thecovering along the epithelium is inhibited when tear liquid is pumped,in accordance with embodiments of the present invention. The axis of theeye can rotate superiorly such that the covering slides along the upperlid and the lower lid. The axis of the eye may comprise one or moreknown axis of the eye and can be determined in many ways by a person ofordinary skill in the art.

FIG. 3G shows a side view sectional view of the covering of FIG. 3E withthe eyelids opening, in accordance with embodiments of the presentinvention. The opening of the eyelids decreases pressure and allows theouter portion of the covering above the outer portion of the cornea tomove away from the cornea. The tear liquid TL may pass throughfenestrations 100F and into the chamber 100C. The outer portion of thecovering comprising portion 130 and flange 120F can contact theconjunctiva to inhibit tear flow and may seal the covering.

FIG. 3H shows a side view sectional view of the covering of FIG. 3E withthe eyelids located at an intermediate location such that the chambercomprises an intermediate configuration 100C12 volume, in accordancewith embodiments. The optical component 100A comprising inner portion110 may comprise sufficient rigidity and resistance to deflection so asto provide vision for the patient when the covering comprisesintermediate portion 100C12 having outer portion 120 deflected so as todecrease volume of chamber 100C. For example, the patient can close theeyelids to the pupil margin to deflect the outer portion and the opticalcomponent 100A and inner portion 110 can remain substantiallyundeflected such that the patient can have vision of 20/20 or better(metric 6/6 or better) with a portion of one or more eye lids contactingthe inner portion 110. Opening of the eyelids can increase the chambervolume and pump tear liquid and closing of the eyelids can decreasechamber volume and pump tear liquid.

FIG. 3I shows a side view sectional view of the covering of FIG. 1C4placed on the eye with hydrogel contacting the eye. The covering 100comprises the layer of hydrogel material 120MHG extending along theposterior surface of the covering so as to contact the eye with at leasta portion of the hydrogel layer. The covering 100 can be dimensioned toform chamber 100C defined at least in part with the layer of hydrogelmaterial. The fenestration may extend through the hydrogel layer so asto provide pumping as described herein. Alternatively or in combination,the posterior end of the fenestration can be covered with the hydrogelmaterial to couple the cornea to the fenestration with the layer ofhydrogel material. The fenestrations covered with the layer of hydrogelmaterial 120MHG can be located along the deflectable portion of thecovering so as to encourage movement of water and therapeutic agentsalong the hydrogel material, for example when the eye blinks. Thehydrogel layer may comprise a medium to pass liquid and therapeuticagent from the fenestration to a desired location of the cornea, forexample with wicking of the liquid and therapeutic agent to a centrallocation of the cornea. The covering comprising the hydrogel layerextending along the lower surface as described herein can be fit to anunablated eye to provide refractive correction or fit to an ablated eyeas described herein.

Clinical testing in accordance with embodiments has shown that thecurved portions of the covering can be fit with on K-values inaccordance with corneal curvatures and sag heights and limbus sagheights and conjunctiva sag heights of a patient population.

Appendix I shown herein below provides dimensions and fit parameters forcovering 100 in accordance with embodiments and teachings as describedherein. The coverings may comprise one or more of the materials in the Aseries Tables shown herein, for example. The dimensions and fitparameters of the coverings can provide pumping of the tear liquid whenplaced on the cornea in accordance with embodiments described herein.The tables of Appendix I identify the coverings for use with steep Kcorneas, medium K corneas and flat K corneas, for example. The K valueslisted can be based on population norms, such that the coverings providepumping as described herein when placed on the eye. The coverings can beused with non-ablated eyes or ablated eyes, and the covering can beidentified at least in part based on the first inner curvature R1.

Table B1 shows covering 100 having a diameter of approximately 14 mmacross and can be fit on K or flatter, for example as described herein.The table lists R1 corresponding to the center ablated portion of thecornea. The inner portion 110 comprising optical component 100A andinner coupling component 100B1 has dimension R1 extends about 5 mmacross, and the ablation zone can be larger, for example about 6 mm. Theportion corresponding to radius R1B1 has dimensions of about 5-7 mmacross, and the curvature can be expressed with keratometry values(K-values) corresponding to the optical power of the eye in Diopters(D). The portion corresponding to radius R1B2 has dimensions of about7-9 mm across. The portion corresponding to radius R1B3 has dimensionsof about 9-11 mm across. The portion corresponding to R1C1 can extendfrom about 11 to 13.5 mm across, and may comprise curvature having oneor more values between portion R1B3 and portion R1C2, for example aradius of curvature between about 8 mm and about 12 mm such as about 10mm. The portion corresponding to R1C2 can extend from about 13.5 to 14mm across. The sag height of the portion R1C2 can be from about 3.1 toabout 3.4 mm, for example. The portion corresponding to R1C1 can be fitto the cornea in many ways as described herein, for example with thetangent of portion R1C1 aligned with R1B3 on the inner boundary and R1C2along an outer boundary so as to inhibit ridge formation as describedherein.

Table B2 shows covering 100 having a diameter of approximately 14 mmacross and can be fit on K or flatter, for example as described herein.The table lists R1 corresponding to the center ablated portion of thecornea. The inner portion 110 comprising optical component 100A andinner coupling component 100B1 has dimension R1 extends about 5 mmacross, and the ablation zone can be larger, for example about 6 mm. Theportion corresponding to radius R1B1 has dimensions of about 5-7 mmacross, and the curvature can be expressed with keratometry values(K-values) corresponding to the optical power of the eye in Diopters(D). The portion corresponding to radius R1B2 has dimensions of about7-9 mm across. The portion corresponding to radius R1B3 has dimensionsof about 9-11 mm across, and these values range from about 35.75 toabout 40, such that each value is somewhat flatter at the peripheralportion than corresponding values of Table B1. For example, Table B1lists the values for R1B3 as having a range from about 36.75 to about41D. The portion corresponding to R1C1 can extend from about 11 to 13.5mm across. The portion corresponding to R1C2 can extend from about 13.5to 14 mm across. The sag height of the portion R1C2 can be from about3.1 to about 3.4 mm, for example. The portion corresponding to R1C1 canbe fit to the cornea in many ways as described herein, for example withthe tangent of portion R1C1 aligned with R1B3 on the inner boundary andR1C2 along an outer boundary so as to inhibit ridge formation asdescribed herein.

Table B3 shows covering 100 having a diameter of approximately 16 mmacross and can be fit on K or flatter, for example as described herein.The table lists R1 corresponding to the center ablated portion of thecornea. The inner portion 110 comprising optical component 100A andinner coupling component 100B1 has dimension R1 extends about 5 mmacross, and the ablation zone can be larger, for example about 6 mm. Theportion corresponding to radius R1B1 has dimensions of about 5-7 mmacross, and the curvature can be expressed with keratometry values(K-values) corresponding to the optical power of the eye in Diopters(D). The portion corresponding to radius R1B2 has dimensions of about7-9 mm across. The portion corresponding to radius R1B3 has dimensionsof about 9-10.5 mm across, and these values range from about 36.75 toabout 41. The portion corresponding to R1C can extend from about 13 toabout 16 mm across. The sag height of the portion R1C2 can be less thanabout 3.6 mm, for example, such that portion R1C2 can be deflected whenplaced on the eye. The portion corresponding to R1C1 can be fit to thecornea in many ways as described herein.

Table B4 shows covering 100 having curvatures for use with non-ablatedeyes so as to pump tear liquid as described herein, for example with anextended wear contact lens. Covering 100 has a diameter of approximately14 mm across and can be fit on K or flatter, for example as describedherein. The table lists R1 corresponding to the center ablated portionof the cornea. The inner portion 110 comprising optical component 100Aand inner coupling component 100B1 has dimension R1 extends about 5 mmacross. The curvatures of the inner portion corresponding to R1 havecurvature values corresponding to optical powers from about 39 D toabout 48D, which can be based on population data for unablated eyes andcombined with the curvatures for portions R1B1 to R1B3 and R1C1 andR1C2, for example. The portion corresponding to radius R1B1 hasdimensions of about 5-7 mm across, and the curvature can be expressedwith keratometry values (K-values) corresponding to the optical power ofthe eye in Diopters (D). The portion corresponding to radius R1B2 hasdimensions of about 7-9 mm across. The portion corresponding to radiusR1B3 has dimensions of about 9-11 mm across. The portion correspondingto R1C1 can extend from about 11 to about 13.5 mm across. The portioncorresponding to R1C2 can extend from about 13.5 to 14 mm across. Thesag height of the portion R1C2 can be from about 3.1 to about 3.4 mm,for example. The portion corresponding to R1C1 can be fit to the corneain many ways as described herein, for example with the tangent ofportion R1C1 aligned with R1B3 on the inner boundary and R1C2 along anouter boundary so as to inhibit ridge formation as described herein.

Although Tables B1-B4 list specific curvature values by way of example,a person of ordinary skill in the art can determine many curvaturevalues based on the teachings and embodiments described herein and oneor more of the curvatures can be combined with an aspheric surface, forexample an aspheric surface having a conic constant.

Methods and Apparatus to Identify Coverings for Eye Treatment

FIG. 4 shows apparatus 200 and a plurality 208 of coverings to treat aneye. The apparatus 200 comprises a cornea and sclera eye measurementsystem 202, a wavefront measurement system, a laser ablation system 204,a topography measurement system 205, a user device 206 and the pluralityof coverings 208.

The plurality of coverings 208 may comprise coverings 100 as describedherein or commercially available coverings identified based on theteachings as described herein. The plurality of coverings 208 maycomprise an inventory of coverings comprising a first covering, a secondcovering, a third covering, and up to an Nth covering.

The sclera measurement system 202 may comprise a processor having acomputer readable memory and communication circuitry. The sclerameasurement system may measure the conjunctiva over the sclera, and maymeasure the cornea when the sclera is measured. The cornea and sclerameasurement system 202 may comprise a system to measure the cornea andthe sclera to determine the shape of the covering to fit the eye. Thecornea and sclera measurement system 202 may comprise components of afluorescence topography based system for example components of thesystem commercially available from PAR technologies. The system may bemodified so as to measure at least about 14 mm across the conjunctiva,sclera and cornea, for example.

The laser ablation system 204 may comprise a processor having a computerreadable memory and communication circuitry, and may comprise acomponents of a commercially available excimer laser ablation systemavailable from such as the Wavelight Allegretto Wave Eye-Q laserablation system commercially available from Alcon, the Technolas laserablation system commercially from Bausch and Lomb, the Star laserablation system commercially available from Abbott Medical Optics, orthe MEL laser ablation system commercially available from Meditech, forexample.

The corneal topography measurement system 205 may comprise a processorhaving a computer readable memory and communication circuitry. Thecorneal topography measurement system 205 may comprise one or more of aPlacido ring based system, a Scheimpflug imaging based system, or aflorescence topography based system, for example. The corneal topographymeasurement system may comprise a commercially available Placido Ringbased system: such as Orbscan™, Atlas™, Keratron™, TMS™, Magellan™,iTrace™ or a Pentacam™, for example. The corneal topography system maycomprise as Scheimpflug system: such as the commercially availablePentacam™ and Galilei™. The commercially available corneal topographybased system may comprise a fluorescence topography system such as thePAR corneal topography system.

The user communication device 206 may comprise a processor having acomputer readable memory, communication circuitry and a display, forexample a personal digital assistance such as an iPhone™, an iPad™, aBlackberry™, a tablet PC. The plurality of coverings 208 may comprise afirst covering 100, a second covering 100 and an Nth covering 100, forexample a 10th covering 100. The plurality of coverings may comprise aninventory of coverings having shape profiles, sizes, moduli and rigidityso as to treat the eye as described herein.

The eye measurement system may measure the eye from the cornea to thesclera to identify the covering, for example based on curvature of thesclera, curvature of the cornea, and curvature of the ablated portion ofthe cornea.

The above systems and components can be interchanged and combined inmany ways.

For example, the sclera measurement system can be used to measure thetopography of the cornea to fit the covering 100. The laser ablationsystem 204 may be combined with one or more measurement systems. Forexample, the Orbscan Placido ring based system may be combined with aTechnolas laser ablation system and the Zyoptix wavefront measurementsystem, each available from Bausch and Lomb. The commercially availableSTAR™ excimer laser ablation system may be combined with a WaveScan™wavefront measurement system, both available from Abbot Medical Optics.The commercially available MEL laser ablation system may be combinedwith the Atlas Placido topography system, for example commerciallyavailable form Zeiss Meditec. The wavefront system and refractionmeasurement system may comprise a combined Hartmann Shack topography andwavefront system, or a full gradient topography system, for example asis commercially available from Wavefront Sciences, Inc.

FIG. 4A shows data structures 200 and a method 300 of identifying acovering. The data structures 200 may comprise data structures of one ormore of the system 202, the system 204, the device 206, for example, andmay comprise data structures of a distributed processor system.

A step 310 inputs data 210

A step 320 inputs patient measurement data 220

A step 321 determines refractive error 222. The refractive error 222 maycomprise one or more of:

sphere (manifest), cylinder, axis

aberrations, coma, spherical, Zernicke

wavefront profile map

A step 322 measures corneal topography (Kinner pre, Kouter pre) 224. Thecorneal topography data 224 may comprise one or more of:

curvature (1/R) and optical power (D)

asphericity

cylinder

aberrations

elevation

sag height corneal vertex to limbus to sclera

A step 323 measure limbus measurement data 226. The data 226 maycomprise one or more of:

A diameter or a sag height of the limbus, for example the sag height anddiameter of the limbus

A step 324 measures scleral measurement data 228. The data 228 maycomprise one or more of:

curvature of sclera, a sag height of the sclera at an axial location, oran angle of the sclera at the axial location, for example a sag heightwhere an outer portion of the covering 100 contacts the sclera.

A step 325 determines age data 229 and ethnicity data 229B, for examplecorresponding to eye color and size and pupil size

A step 330 determines laser ablation data—230. The laser ablation data230 may comprise one or more of:

manufacturer 232 determined with a step 331;programmed ablation (e.g. sphere, cylinder& axis) 234 determined withstep 332; andablation profile data 236 determined with step 332.

The ablation profile data may comprise one or more of:

dimensions of outer Boundary

-   -   circular, oval, elliptical

maximum depth of ablation

3D topography shape of ablation

a Q value for an optimized aspheric ablation

a physician nomogram, for example to adjust ablation depth

A step 340 determines input covering data—240

A step 341 identifies available coverings 241

A step 342 provides a Table of available coverings—242. The table 242may comprise one or more of:

-   -   (N dimensional array);    -   outer portion D/curvature/R (Dimension X);    -   inner portion D/curvature/R (Dimension Y);    -   limbal portion diameter (Dimension Z);    -   limbal portion D/cuvature/R (Dimension M);    -   scleral portion D/curvature/R (Dimension N);

A step 342M determines Manufacturer—242M

A step 343 determines rigidity—243

A step 344 determines Portions (inner, outer, scleral)—244

A step 345 determines Dimensions of each portion—245

A step 346 determines Rigidity of each portion—246

A step 345 determines Thickness of each Portion—247

A step 346 determines Modulus of each Portion—248

A step 350 determines Ablated Corneal Profile Data—250. The data 250 maycomprise one or more of:

e.g. Subtract Ablation Profile Data from Corneal Topography Data

e.g. Kinner post=Kinner pre−Sph. Equiv. of ablation

(Sph. Equiv.=Sphere+Cylinder/2)

A step 360 outputs Ablated Corneal Profile Data—260

A person of ordinary skill in the art will recognize that steps 350 and360 may not be necessary when the cornea comprises an unablated cornea.Alternatively or in combination, the ablation profile can be set to zeroto determine the covering for a non-ablated cornea.

A step 361 determines Inner ablated portion profile data may compriseone or more of:

e.g. Kinner post

e.g. 3D profile of ablated cornea

A step 362 determines outer unablated portion data

e.g. K (Sph. Equiv) at 5 mm=Kouter

A step 364 provides one or more of the Limbus Diameter or the limbus sagheight

A step 365 provides one or more of the Scleral Curvature or the scleralsag height at an axial location of the sclera, for example.

A step 370 determines fit identification parameters based on corneaoutput data 270

The cornea output data may comprise fit profiles for an unablated corneasuch as a cornea to receive an extended wear contact lens for refractivecorrection, or fit profiles for an ablated cornea such as a corneareceiving a PRK ablation, or combinations thereof.

A step 371 Determines Unablated Outer Corneal Portion Fit ParameterX—272. The parameter 272 may comprise one or more of:

e.g. X=(Kouter)−(Outer Fit offset)

e.g. Outer fit offset within range from 0 to 2

e.g. X=(Kouter in Diopters)−(Fit offset within range from 0 to 2.0D)

e.g. X−(Kouter in Diopters)−(1D)

A step 372. Determine Inner Corneal Fit Parameter Y—274. The parameter274 may comprise one or more of:

e.g. Y=(Kinner)−(Vision/Epi promoting offset)

e.g. Y=(Kinner)−(Vision/Epi promoting offset within a range from about−1 to 2.5)

e.g. Y=(Kinner in Diopters)−(Koffset within range from about 1 to about2.5)

A step 373 Determines a Limbal Fit Parameter Z—276, such as

e.g. Z=Limbus diameter or sag height or combinations thereof

A step 374 Determines Scleral D/curvature/R (Dimension N)—278, such as

e.g. M=D/curvature/R of sclera or sag height of the sclera at an axiallocation or a combination thereof

A step 380 identifies a Shield Based on Fit IdentificationParameters—280. The identification of the shield covering can be basedon the fit identification parameters and the array of data comprisingthe table of available coverings 242.

A step 381 Determines shield based on values of Dimensions (X, Y, . . .N)—282

A step 382 Looks up shield identifier in table based on values of eachof Dimensions of (X, Y, . . . N)—284, such as

e.g. look up shield in XY table

A step 383 Determines when fit is acceptable based on profiledifferences—286

A step 384 Assigns Shield—288

A step 390 Displays shield identifier to health care provided—290

Table I. shows a look up table in accordance with embodiments. The lookup table comprises a unique identifier.

TABLE I Look Up Table for Shield 100 X X = X = X = X = Outer power Outerpower Outer power Outer power Y 38-40 D 38-40 D 38-40 D 38-40 D Y = A1B1 C1 D1 Inner Power 36-38 D Y = A2 B2 C2 D2 Inner power 38-40 D Y = A3B3 C3 D3 Inner Power 40-42 D Y = A4 B4 C4 D4 Inner power 42-44 D

The method 300 can be performed separately from the structures 200.

FIG. 4B shows data structures and the method of identifying the coveringas FIG. 4A, in which the fit parameters comprise a two fit parametersand the data array comprises a two dimensional look up table. The K's ofFIG. 4B refer to the optical power of the cornea in Diopters (D).

It should be appreciated that the specific steps illustrated in FIGS. 4Aand 4B provide a particular method of identifying a covering, accordingto embodiments of the present invention. Other sequences of steps mayalso be performed according to alternative embodiments. For example,alternative embodiments of the present invention may perform the stepsoutlined above in a different order. Moreover, the individual stepsillustrated in FIGS. 4A and 4B may include multiple sub-steps that maybe performed in various sequences as appropriate to the individual step.Furthermore, additional steps may be added or removed depending on theparticular applications. One of ordinary skill in the art wouldrecognize many variations, modifications, and alternatives.

Tables A to C show tables and data structures suitable for incorporationwith data structures 200 and method 300. The tables of Appendix I showsimilar data structures for a plurality of coverings listed in thetables that can be identified similarly.

TABLE A Pre-op Screening Log center Mid SHIELD Subject ID SphereCylinder K (D) K (D) CODE EMT OD −1.25 −0.5 42.9 42.2 DZ EMT OS −1.25−0.5 42.0 41.7 DZ AEC OD −1.75 −1.50 44.0 43.4 EC AEC OS −1.25 −0.2543.5 43.0 EC JML OD −2.25 −1 43.4 42.9 DZ JML OS −2.25 −0.5 43.4 43.1 EAEGT OD −1.50 −0.75 43.7 43.4 EC EGT OS −2.00 −0.25 44.6 44.0 EC REC OD−2.75 −0.5 44.3 43.8 EA REC OS −2.50 −0.5 44.2 43.8 EA JGG OD −1.00−0.75 42.6 42.4 DZ JGG OS −1.50 −1 42.5 42.3 DZ NGT OD −2.50 −1.25 44.543.7 EA NGT OS −3.00 −1.25 44.1 43.5 DY DCG OD −0.75 −0.5 43.8 43.4 EFDCG OS −1.25 0 43.9 43.6 EF JRJ OD −2.50 0 44.1 43.6 EC JRJ OS −2.00 043.6 43.1 EC REC OD −2.75 −0.5 44.3 43.8 EA REC OS −2.50 −0.5 44.2 43.8EA DLL OD −2.75 −0.5 44.1 43.8 EA DLL OS −2.75 0 45.0 44.5 ED

Table A shows a screening log having a plurality of patients and acovering identified for each eye of each patient, in accordance withembodiments.

Table A shows: a subject ID; eye (OD or OS): refraction includingsphere, cylinder: pre-op K(D) in spherical equivalents for the innerportion; Mid K in spherical equivalents in the outer portion; and thecorresponding shield code comprising the unique identifier correspondingthe covering that fits the patient. For patient EMT OD, the refractionis −1.25 sph, −0.5 cyl, the pre-op center K is 42.9 D and the midperiphery K is 42.2 D, such that the identified shield code is DZ. If apatient cannot be fit, a code “not a candidate” can be assigned and nocovering is provided for the patient.

Table B comprises an array of data to identify a covering for the eyefrom among a plurality of coverings, and the properties for a pluralityof coverings and the corresponding properties of each covering 100 ofthe plurality. As used herein, a covering encompasses a shield, andcorresponding unique identifier can also be referred to herein as acode.

Mid-Peripheral/ Center/Inner Portion Mid/Outer Portion Center FittingOuter Portion SHIELD Curve Curve Range Fitting Range UNIQUE R1Center/INNER R1B (−1.00 to −2.00) (0 to −1.50) ID Center OPTICAL POWERMid Mid min max min max Code (mm) (D) (mm) (D) (D) (D) (D) (D) DV 9.037.5 8.1 41.5 38.50 39.50 41.50 43.00 DW 9.0 37.5 7.8 43.0 38.50 39.5043.00 44.50 DX 8.8 38.5 8.1 41.5 39.50 40.50 41.50 43.00 DY 8.8 38.5 7.843.0 39.50 40.50 43.00 44.50 DZ 8.5 39.5 8.1 41.5 40.50 41.50 41.5043.00 EA 8.5 39.5 7.8 43.0 40.50 41.50 43.00 44.50 EB 8.5 39.5 7.6 44.540.50 41.50 44.50 46.00 EC 8.3 40.5 7.8 43.0 41.50 42.50 43.00 44.50 ED8.3 40.5 7.6 44.5 41.50 42.50 44.50 46.00 EF 8.1 41.5 7.8 43.0 42.5043.50 43.00 44.50 EG 8.1 41.5 7.6 44.5 42.50 43.50 44.50 46.00 EG 8.141.5 7.6 44.5 42.50 43.50 44.50 46.00

As shown in Table B, the plurality of coverings has an inner radius ofcurvature R1 corresponding to the inner portion 110, and an outer radiusof curvature R1B corresponding to an outer portion 120 of the covering.The radius of curvature R1 of the inner portion 110 is listed in mm andalso in optical power in Diopters. The “Center Fitting Range” (−1 to −2)shows that the inner portion can be fit with a covering having acurvature less than the ablated cornea, so as to promote epithelialregeneration. The covering can deflect and conform at least partially tothe eye with the amount relative rigidity as described herein, forexample an amount corresponding to a modulus of about 20 MPa and athickness of about 200 um. The outer portion 120 can have a fittingrange of about 1.5D, for example from about 41.5D to about 43D. Theouter portion 120 corresponding to the unablated portion of the corneacan be flatter than the outer portion of the cornea, for example flatterwithin a range from about 0 to 1.5D. The flatter outer portion 120 canbe coupled to a scleral portion 130, that can contact the conjunctivaand couple to the sclera. The scleral portion 130 can resist movementwhen the inner portion 110 and outer portion 120 provide the environment100E to promote smooth regeneration of the epithelium.

TABLE C Values to Identify Coverings. Shield allocation Pre-op PlannedShield Shield Subj Sph Cyli SE CTR/Inner Outer Inner SHIELD CTR/InnerOuter CTR Outer ID (D) (D) (D) K (D) K (D) K (D) CODE K (D) K (D) diff(D) diff (D) EMT OD −1.25 −0.5 −1.50 42.9 42.2 41.40 DZ 39.50 41.50−1.90 −0.70 AGP OS −1.25 −0.25 −1.38 42.0 41.7 40.63 DZ 39.50 41.50−1.13 −0.20 AML OD −1.75 −1.5 −2.50 44.0 43.4 41.50 EC 40.50 43.00 −1.00−0.40 AML OS −1.25 −0.25 −1.38 43.5 43.0 42.13 EC 40.50 43.00 −1.63 0.00AMZ OD −2.25 −1 −2.75 43.4 42.9 40.65 DZ 39.50 41.50 −1.15 −1.40 AMZ OS−2.25 −0.5 −2.50 43.4 43.1 40.90 EA 39.50 43.00 −1.40 −0.10 BPS OD −1.5−0.75 −1.88 43.7 43.4 41.83 EC 40.50 43.00 −1.33 −0.40 BPS OS −2 −0.25−2.13 44.6 44.0 42.48 EC 40.50 43.00 −1.98 −1.00 DGU OD −2.75 −0.5 −3.0044.3 43.8 41.30 EA 39.50 43.00 −1.80 −0.80 DGU OS −2.5 −0.5 −2.75 44.243.8 41.45 EA 39.50 43.00 −1.95 −0.80 JGG OD −1 −0.75 −1.38 42.6 42.441.23 DZ 39.50 41.50 −1.73 −0.90 JGG OS −1.5 −1 −2.00 42.5 42.3 40.50 DZ39.50 41.50 −1.00 −0.80 KGC OD −2.5 −1.25 −3.13 44.5 43.7 41.38 EA 39.5043.00 −1.88 −0.70 KGC OS −3 −1.25 −3.63 44.1 43.5 40.48 DY 38.50 43.00−1.98 −0.50 RBT OD −0.75 −0.5 −1.00 43.8 43.4 42.80 EF 41.50 43.00 −1.30−0.40 RBT OS −1.25 0 −1.25 43.9 43.6 42.65 EF 41.50 43.00 −1.15 −0.60SVD OD −2.5 0 −2.50 44.1 43.6 41.60 EC 40.50 43.00 −1.10 −0.60 SVD OS −20 −2.00 43.6 43.1 41.60 EC 40.50 43.00 −1.10 −0.10 −2.75 −0.5 −3.00 44.343.8 41.30 EA 39.50 43.00 −1.80 −0.80 −2.5 −0.5 −2.75 44.2 43.8 41.45 EA39.50 43.00 −1.95 −0.80 −2.75 −0.5 −3.00 44.1 43.8 41.10 EA 39.50 43.00−1.60 −0.80 −2.75 0 −2.75 45.0 44.5 42.25 ED 40.50 44.50 −1.75 0.00

Table C shows the covering assigned to each eye of each patient based onthe pre-op refraction, the pre-op K's of the inner portion and the outerportion, the array of data corresponding to the fit coverings and theparameters of the coverings, and the logic steps to assign the coveringbased on the teachings described herein. For example, patient EMT isassigned a covering DZ based on the outer K of 42.2 and the plannedinner K of 41.4 so as to provide a covering flatter than the ablatedcornea by about 1.9 D. The “−” of the −1.9 D indicates that the coveringcorresponds to an optical power less than the ablated cornea by 1.9D.The outer difference of −0.70 D indicates that the outer unablatedportion of the cornea is fit with a covering having a curvature lessthan the outer portion of the cornea. As the covering may comprise thescleral portion 130 having radius of curvature R1C, the movement of thecovering on the eye can be resisted when the scleral portion contactsthe conjunctiva to couple to the sclera.

While the covering can be identified in many ways, the covering can beidentified based on the covering within a range of values and a sequenceof logic steps, for example.

TABLE D Inventory of coverings. SHIELD Code Qty Used DV 18 0 DW 9 0 DX13 0 DY 16 1 DZ 16 6 EA 10 7 EB 12 0 EC 15 6 ED 17 1 EF 20 0 EG 18 3 EG14 0

The inventory of coverings can show a number of coverings available foreach covering and the number of coverings used, such that the healthcare provider can determine whether additional coverings should beordered, for example.

The embodiments as described herein can be combined in many ways. Asused herein like alphanumeric characters describe like structures,elements and methods and are interchangeable among the figures andsupporting text to the full extent described and as understood by aperson of ordinary skill in the art in accordance with the embodimentsdescribed herein.

While the exemplary embodiments have been described in some detail, byway of example and for clarity of understanding, those of skill in theart will recognize that a variety of modifications, adaptations, andchanges may be employed. Hence, the scope of the present inventionshould be limited solely by the appended claims.

APPENDIX I

TABLE B1 14 mm R1 R1B1 R1B2 R1B3 R1 C2 multicurve center 5-7 mm 7-9 mm9-11 mm 13.5-14 mm SAG designs BC (D) K (D) K (D) K (D) K (D) mm DIASteep K 36.5 43.50 42.25 39.50 <12 mm BC (140 micron thick) 3.1-3.413.8-14.1 mm Medium 36.5 42.00 40.75 38.25 <12 mm BC (140 micron thick)3.1-3.4 13.8-14.1 mm Flat K 36.5 40.50 39.25 36.75 <12 mm BC (140 micronthick) 3.1-3.4 13.8-14.1 mm Steep K 38.5 44.25 43.00 40.25 <12 mm BC(140 micron thick) 3.1-3.4 13.8-14.1 mm Medium 38.5 42.75 41.50 39.00<12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm Flat K 38.5 41.2540.00 37.50 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm Steep K40.5 45.00 43.75 41.00 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mmMedium 40.5 43.50 42.25 39.75 <12 mm BC (140 micron thick) 3.1-3.413.8-14.1 mm Flat K 40.5 42.00 40.75 38.25 <12 mm BC (140 micron thick)3.1-3.4 13.8-14.1 mm

TABLE B2 Flatter periphery design 14 mm R1 R1B1 R1B2 R1B3 R1 C2multicurve center 5-7 mm 7-9 mm 9-11 mm 13.5-14 mm SAG designs BC (D) K(D) K (D) K (D) K (D) (mm) DIA Steep K 36.5 43.50 42.25 38.50 <12 mm BC(140 micron thick) 3.1-3.4 13.8-14.1 mm Medium 36.5 42.00 40.75 37.25<12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm Flat K 36.5 40.5039.25 35.75 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm Steep K38.5 44.25 43.00 39.25 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mmMedium 38.5 42.75 41.50 38.00 <12 mm BC (140 micron thick) 3.1-3.413.8-14.1 mm Flat K 38.5 41.25 40.00 36.50 <12 mm BC (140 micron thick)3.1-3.4 13.8-14.1 mm Steep K 40.5 45.00 43.75 40.00 <12 mm BC (140micron thick) 3.1-3.4 13.8-14.1 mm Medium 40.5 43.50 42.25 38.75 <12 mmBC (140 micron thick) 3.1-3.4 13.8-14.1 mm Flat K 40.5 42.00 40.75 37.25<12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm

TABLE B3 Large shield (16 mm) R1 R1B1 R1B2 R1B3 multicurve center 5-7 mm7-9 mm 9-10.5 mm 10.5-13 mm SAG designs BC K (D) K (D) K (D) K (D) 13-16mm (mm) DIA Steep K 36.5 43.50 42.25 39.50 <10.0 mm/33.75 D <14.5 mm/23D ≦3.6 15.6-16.1 mm Medium 36.5 42.00 40.75 38.25 <10.0 mm/33.75 D <14.5mm/23 D ≦3.6 15.6-16.1 mm Flat K 36.5 40.50 39.25 36.75 <10.0 mm/33.75 D<14.5 mm/23 D ≦3.6 15.6-16.1 mm Steep K 38.5 44.25 43.00 40.25 <10.0mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mm Medium 38.5 42.75 41.50 39.00<10.0 mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mm Flat K 38.5 41.25 40.0037.50 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mm Steep K 40.545.00 43.75 41.00 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.6 15.6-16.1 mmMedium 40.5 43.50 42.25 39.75 <10.0 mm/33.75 D <14.5 mm/23 D ≦3.615.6-16.1 mm Flat K 40.5 42.00 40.75 38.25 <10.0 mm/33.75 D <14.5 mm/23D ≦3.6 15.6-16.1 mm

TABLE B4 R1 R1B1 R1B2 R1B3 R1C Multicurve center BC 5-7 mm 7-9 mm 9-11mm 13.5-14 mm SAG CL designs (D) K (D) K (D) K (D) K (D) (mm) DIA CLcentral Steep K 40 41.75 39.00 39.00 <12 mm BC (140 micron thick)3.1-3.4 13.8-14.1 mm curve 1 Medium 40.00 39.75 37.25 37.25 <12 mm BC(140 micron thick) 3.1-3.4 13.8-14.1 mm Flat K 40.00 37.75 35.25 35.25<12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm CL central Steep K42.00 43.75 41.00 41.00 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1mm curve 2 Medium 42.00 41.75 39.25 39.25 <12 mm BC (140 micron thick)3.1-3.4 13.8-14.1 mm Flat K 42.00 39.75 37.25 37.25 <12 mm BC (140micron thick) 3.1-3.4 13.8-14.1 mm CL central Steep K 44.000 44.75 42.0042.00 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm curve 3 Medium44.00 43.25 40.75 40.75 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1mm Flat K 44.00 41.75 39.25 39.25 <12 mm BC (140 micron thick) 3.1-3.413.8-14.1 mm CL central Steep K 46.00 46.75 44.00 44.00 <12 mm BC (140micron thick) 3.1-3.4 13.8-14.1 mm curve 4 Medium 46.00 45.25 42.7542.75 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm Flat K 46.0043.75 41.25 41.25 <12 mm BC (140 micron thick) 3.1-3.4 13.8-14.1 mm

What is claimed is:
 1. A method of treating an eye of a patient, the eyehaving a cornea, the method comprising: measuring the eye to determinedata of the eye corresponding to an inner ablated portion of the corneaand an outer unablated portion of the cornea away from the ablatedportion; and identifying a covering of a plurality of coverings to treatthe eye based on the data of the eye and an array of data correspondingto the plurality of therapeutic coverings.
 2. The method of claim 1further comprising placing the covering on the eye.
 3. The method ofclaim 1 wherein the covering comprises an inner covering portion and anouter covering portion, the inner covering portion contacting the innerablated portion of the cornea and an outer covering portion contactingan unablated portion when placed on the cornea and wherein the innercovering portion prior to placement on the eye has a covering curvatureno more than a curvature of the ablated portion of the cornea andwherein the outer covering portion comprises a curvature prior toplacement on the eye no more than the outer unablated portion of thecornea and wherein the covering resists movement of the inner portionwhen placed on the eye.
 4. The method of claim 3 wherein the outerportion of the covering extends to a conjunctiva of the eye and couplesto the sclera of the eye to resist movement of the inner portion.
 5. Themethod of claim 3 wherein the inner portion of the covering prior toplacement comprises a substantially uniform thickness and an amount ofcurvature corresponding to less optical power than the optical power ofthe ablated portion of the cornea, the amount of curvature of the innerportion prior to placement within a range from about −1D to about −3Drelative to the ablated portion of the cornea.
 6. The method of claim 5wherein the inner covering deflects at least about 1D so as to conformat least partially to the ablation and promote smooth epithelialregeneration and vision.
 7. The method of claim 3 wherein the innerportion of the covering comprises an amount of rigidity within a rangefrom about 1E-4 to about 5E-4 (Pa*m̂3) and the outer portion of thecovering comprises an outer amount of rigidity less than the amount ofrigidity of the inner portion.
 8. The method of claim 1 whereinmeasuring the eye comprises determining a conjunctiva sag height, theconjunctiva sag height corresponding to a portion of a conjunctiva ofthe eye at a radial location away from a reference axis of the eye andwherein the covering comprises a covering sag height at a coveringlocation corresponding to the radial location of the portion ofconjunctiva and wherein the covering is identified such that thecovering sag height is greater than the conjunctiva sag height.
 9. Themethod of claim 8 wherein the covering is deflected at the coveringlocation when the covering is placed on the eye.
 10. The method of claim8 wherein the conjunctiva sag height is determined based on ameasurement of a sclera of the eye corresponding to the radial location.11. The method of claim 1 wherein measuring the eye comprisesdetermining a limbus sag height, the limbus sag height corresponding toa portion of a limbus of the eye at a radial location away from areference axis of the eye and wherein the covering comprises a coveringsag height at a covering location corresponding to the radial locationof the portion of the limbus and wherein the covering is identified suchthat the covering sag height is no more than the limbus sag height. 12.The method of claim 11 wherein the covering is deflected a first amountat a first covering location corresponding to a portion of theconjunctiva when the covering is placed on the eye and wherein thecovering is deflected a second amount at a second covering locationcorresponding to a portion of the limbus when the covering is placed onthe eye, the second amount less than the first amount such that pressurefrom the covering to the limbus is inhibited.
 13. The method of claim 1wherein the covering comprises an inner portion having a hydrogel layerextending along a lower surface to contact the ablated portion and theunablated portion of the cornea and wherein the covering comprises anouter portion comprising a sticky tacky surface to contact theconjunctiva and inhibit movement of the covering when the inner portioncontacts the cornea.
 14. An apparatus to treat an eye, the apparatuscomprising: an input to receive data of the eye, the data of the eyecorresponding to an inner ablated portion of the cornea and an outerunablated portion of the cornea away from the ablated portion; anoutput; and at least one processor coupled to the input and the output,the at least one processor comprising at least one computer readablememory, the at least one computer readable memory having instructions tostore an array of data corresponding to a plurality of therapeuticcoverings and instructions to identify a covering of the plurality basedon the array and the data of the eye corresponding to the inner ablatedportion and the outer portion.
 15. The apparatus of claim 14 wherein theinstructions are configured to identify a covering having an innerportion comprising a lower surface curvature flatter than the innerablated portion of the eye to inhibit one or more irregularities of theepithelium.
 16. The apparatus of claim 15 wherein the lower surfacecurvature of the identified covering is flatter prior to placement thanthe inner ablated portion of the eye by at least about 1D.
 17. Theapparatus of claim 15 wherein the inner portion of the coveringcomprises a substantially uniform thickness and the instructions areconfigured to identify a covering prior to placement corresponding tohyperopia of the eye to improve vision and inhibit an epithelialirregularity located on an inner portion of the ablation andcorresponding to nearsightedness of the eye.
 18. The apparatus of claim17 wherein the instructions are configured to identify the covering toinhibit formation of the epithelial irregularity based on one or more ofa modulus of the inner portion of the covering, a thickness of the innerportion of the covering, or an amount rigidity of the inner portion ofthe covering.
 19. The apparatus of claim 14 further comprising theplurality of coverings.
 20. The apparatus of claim 14 wherein the arrayof data comprises a plurality of unique identifiers corresponding to theplurality of coverings.
 21. The apparatus of claim 20 wherein theplurality of unique identifiers corresponds to a rigidity of an innerportion of each of the plurality of coverings.
 22. The apparatus ofclaim 20 wherein the covering comprises an amount of rigidity of theinner portion within a range from about 1E-4 Pa*m̂3 to about 5E-4 Pa*m̂3.23. The apparatus of claim 20 wherein the plurality of uniqueidentifiers comprises 10 or more unique identifiers corresponding to anamount rigidity of the inner portion of at least about 3E-4 Pa*m̂3. 24.The apparatus of claim 20 wherein the covering comprises an amount ofrigidity of the inner portion within a range from about 1E-4 Pa*m̂3 toabout 5E-4 Pa*m̂3.
 25. The apparatus of claim 20 wherein the array ofdata comprises a first dimension corresponding to the inner ablatedportion and a second dimension corresponding to the outer portion awayfrom the ablated portion.
 26. The apparatus of claim 25 wherein thearray comprises a table, the first dimension corresponding to rows ofthe table, the second dimension corresponding to columns of the tableand wherein the plurality of unique identifiers is stored in the rowsand the columns of the table.
 27. The apparatus of claim 25 wherein thedisplay is visible to the user and the instructions are configured toshow the unique identifier on the display.
 28. The apparatus of claim20, wherein the instructions are configured to receive a conjunctiva sagheight, the conjunctiva sag height corresponding to a portion of aconjunctiva of the eye at a radial location away from a reference axisof the eye and wherein the instructions are configured such that theidentified covering comprises a covering sag height at a coveringlocation corresponding to the radial location of the portion ofconjunctiva and wherein the instructions are configured such that thecovering sag height is greater than the conjunctiva sag height.
 29. Theapparatus of claim 28 wherein the covering comprises an inner portionhaving a hydrogel layer extending along a lower surface to contact theablated portion and the unablated portion of the cornea and wherein thecovering comprises an outer portion at the covering location comprisinga sticky tacky surface to contact the conjunctiva and inhibit movementof the covering when the inner portion contacts the cornea.
 30. Theapparatus of claim 29 wherein the inner portion of the coveringcomprises a low water content water inhibiting layer beneath thehydrogel layer and the outer portion of the covering at the coveringlocation to contact the conjunctiva comprises a soft hydrophobicmaterial.
 31. The apparatus of claim 30 wherein the water inhibitinglayer comprises silicone elastomer and the hydrogel layer comprisessilicone hydrogel.
 32. The apparatus of claim 28 wherein instructionsare configured such that the identified covering is deflected at thecovering location when the covering is placed on the eye.
 33. Theapparatus of claim 28 wherein the instructions are configured to receivethe conjunctiva sag height based on a measurement of a sclera of the eyecorresponding to the radial location.
 34. The apparatus of claim 14,wherein the instructions are configured to receive a measurement the eyecorresponding to a limbus sag height, the limbus sag heightcorresponding to a portion of a limbus of the eye at a radial locationaway from a reference axis of the eye and wherein the instructions areconfigured such that the covering comprises a covering sag height at acovering location corresponding to the radial location of the portion oflimbus and wherein the instructions are configured such that thecovering sag height is no more than the limbus sag height.
 35. Theapparatus of claim 14, wherein instructions are configured to identifythe covering such that the identified covering is deflected a firstamount at a first covering location corresponding to a portion of theconjunctiva when the covering is placed on the eye and wherein theinstructions are configured to identify the covering such that thecovering is deflected a second amount at a second covering locationcorresponding to a portion of the limbus when the covering is placed onthe eye, the second amount less than the first amount such that pressurefrom the covering over the limbus is inhibited.